Trial Outcomes & Findings for Oral Irritation Study of Two Experimental Mouthrinses (NCT NCT01156376)

NCT ID: NCT01156376

Last Updated: 2015-08-24

Results Overview

Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 80 participants
• Primary outcome timeframe: Screening
• Results posted on: 2015-08-24

Participant Flow

Participant milestones

Measure	19292-116-A Control (Listerine®) Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)	12027-020 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
Overall Study STARTED	27	26	27
Overall Study COMPLETED	26	26	23
Overall Study NOT COMPLETED	1	0	4

Reasons for withdrawal

Measure	19292-116-A Control (Listerine®) Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)	12027-020 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
Overall Study Adverse Event	1	0	1
Overall Study Withdrawal by Subject	0	0	3

Baseline Characteristics

Oral Irritation Study of Two Experimental Mouthrinses

Baseline characteristics by cohort

Measure	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)	12027-020 n=27 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	Total n=80 Participants Total of all reporting groups
Age, Continuous	48.4 years STANDARD_DEVIATION 14.24 • n=5 Participants	37.6 years STANDARD_DEVIATION 14.29 • n=7 Participants	51.0 years STANDARD_DEVIATION 15.03 • n=5 Participants	45.8 years STANDARD_DEVIATION 15.47 • n=4 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	15 Participants n=7 Participants	22 Participants n=5 Participants	57 Participants n=4 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	11 Participants n=7 Participants	5 Participants n=5 Participants	23 Participants n=4 Participants
Region of Enrollment USA	27 participants n=5 Participants	26 participants n=7 Participants	27 participants n=5 Participants	80 participants n=4 Participants

PRIMARY outcome

Timeframe: Screening

Population: Analysis was based on subjects with measurements for this variable.

Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.

Outcome measures

Measure	12027-020 n=27 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Participants With an Abnormal Condition by Anatomical Site at Screening Mucobuccal Fold	0 Percentage of Participants	0 Percentage of Participants	3.8 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Screening Gingiva	3.7 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Screening Tongue	3.7 Percentage of Participants	0 Percentage of Participants	3.8 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Screening Hard/Soft Palate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Screening Uvula/Oropharynx	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Screening Teeth	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Screening Dental Restorations	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Screening Buccal Mucosa	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Screening Labial Mucosa	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Screening Sublingual Mucosa	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 1 - Baseline/Pretreatment

Population: Analysis was based on subjects with measurements for this variable.

Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.

Outcome measures

Measure	12027-020 n=27 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Baseline/Pretreatment Buccal Mucosa	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Baseline/Pretreatment Labial Mucosa	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Baseline/Pretreatment Sublingual Mucosa	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Baseline/Pretreatment Mucobuccal Fold	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Baseline/Pretreatment Gingiva	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Baseline/Pretreatment Tongue	3.7 Percentage of Participants	3.7 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Baseline/Pretreatment Hard/Soft Palate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Baseline/Pretreatment Uvula/Oropharynx	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Baseline/Pretreatment Teeth	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Baseline/Pretreatment Dental Restorations	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 1 - Post-treatment

Population: Analysis was based on subjects with measurements for this variable.

Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.

Outcome measures

Measure	12027-020 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Post-treatment Buccal Mucosa	3.8 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Post-treatment Labial Mucosa	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Post-treatment Sublingual Mucosa	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Post-treatment Mucobuccal Fold	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Post-treatment Gingiva	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Post-treatment Tongue	7.7 Percentage of Participants	18.5 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Post-treatment Hard/Soft Palate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Post-treatment Uvula/Oropharynx	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Post-treatment Teeth	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Post-treatment Dental Restorations	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 3

Population: Analysis was based on subjects with measurements for this variable.

Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.

Outcome measures

Measure	12027-020 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 3 Buccal Mucosa	3.8 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 3 Labial Mucosa	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 3 Sublingual Mucosa	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 3 Mucobuccal Fold	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 3 Gingiva	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 3 Tongue	3.8 Percentage of Participants	25.9 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 3 Hard/Soft Palate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 3 Uvula/Oropharynx	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 3 Teeth	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 3 Dental Restorations	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 5

Population: Analysis was based on subjects with measurements for this variable.

Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.

Outcome measures

Measure	12027-020 n=25 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 5 Sublingual Mucosa	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 5 Mucobuccal Fold	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 5 Buccal Mucosa	4.0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 5 Labial Mucosa	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 5 Gingiva	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 5 Tongue	4.0 Percentage of Participants	22.2 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 5 Hard/Soft Palate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 5 Uvula/Oropharynx	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 5 Teeth	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 5 Dental Restorations	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 24 - Pretreatment

Population: Analysis was based on subjects with measurements for this variable.

Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.

Outcome measures

Measure	12027-020 n=23 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Pretreatment Buccal Mucosa	0 Percentage of Participants	3.7 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Pretreatment Labial Mucosa	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Pretreatment Sublingual Mucosa	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Pretreatment Mucobuccal Fold	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Pretreatment Gingiva	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Pretreatment Tongue	4.3 Percentage of Participants	3.7 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Pretreatment Hard/Soft Palate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Pretreatment Uvula/Oropharynx	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Pretreatment Teeth	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Pretreatment Dental Restorations	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 24 - Post-treatment

Population: Analysis was based on subjects with measurements for this variable.

Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.

Outcome measures

Measure	12027-020 n=23 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=26 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Post-treatment Buccal Mucosa	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Post-treatment Labial Mucosa	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Post-treatment Tongue	4.3 Percentage of Participants	15.4 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Post-treatment Hard/Soft Palate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Post-treatment Uvula/Oropharynx	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Post-treatment Teeth	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Post-treatment Dental Restorations	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Post-treatment Sublingual Mucosa	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Post-treatment Mucobuccal Fold	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Post-treatment Gingiva	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 25

Population: Analysis was based on subjects with measurements for this variable.

Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.

Outcome measures

Measure	12027-020 n=23 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=26 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 25 Buccal Mucosa	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 25 Labial Mucosa	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 25 Sublingual Mucosa	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 25 Mucobuccal Fold	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 25 Gingiva	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 25 Tongue	4.3 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 25 Hard/Soft Palate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 25 Uvula/Oropharynx	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 25 Teeth	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 25 Dental Restorations	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Screening

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=27 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Screening None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Screening Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Screening Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Screening Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Screening

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=27 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Labial Mucosa at Screening None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Labial Mucosa at Screening Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Labial Mucosa at Screening Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Labial Mucosa at Screening Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Screening

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=27 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Screening None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Screening Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Screening Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Screening Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Screening

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=27 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Screening None	100 Percentage of Participants	100 Percentage of Participants	96.2 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Screening Mild	0 Percentage of Participants	0 Percentage of Participants	3.8 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Screening Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Screening Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Screening

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=27 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Gingiva at Screening Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Gingiva at Screening None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Gingiva at Screening Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Gingiva at Screening Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Screening

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=27 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Tongue at Screening Mild	0 Percentage of Participants	0 Percentage of Participants	3.8 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Tongue at Screening None	100 Percentage of Participants	100 Percentage of Participants	96.2 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Tongue at Screening Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Tongue at Screening Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Screening

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=27 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Screening None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Screening Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Screening Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Screening Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Screening

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=27 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Screening None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Screening Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Screening Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Screening Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 1 - Baseline/Pretreatment

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=27 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 1 - Baseline/Pretreatment None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 1 - Baseline/Pretreatment Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 1 - Baseline/Pretreatment Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 1 - Baseline/Pretreatment Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 1 - Baseline/Pretreatment

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=27 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 1 - Baseline/Pretreatment None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 1 - Baseline/Pretreatment Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 1 - Baseline/Pretreatment Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 1 - Baseline/Pretreatment Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 1 - Baseline/Pretreatment

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=27 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 1 - Baseline/Pretreatment None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 1 - Baseline/Pretreatment Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 1 - Baseline/Pretreatment Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 1 - Baseline/Pretreatment Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 1 - Baseline/Pretreatment

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=27 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 1 - Baseline/Pretreatment None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 1 - Baseline/Pretreatment Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 1 - Baseline/Pretreatment Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 1 - Baseline/Pretreatment Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 1 - Baseline/Pretreatment

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=27 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Gingiva at Day 1 - Baseline/Pretreatment None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Gingiva at Day 1 - Baseline/Pretreatment Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Gingiva at Day 1 - Baseline/Pretreatment Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Gingiva at Day 1 - Baseline/Pretreatment Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 1 - Baseline/Pretreatment

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=27 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Tongue at Day 1 - Baseline/Pretreatment None	100 Percentage of Participants	96.3 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Tongue at Day 1 - Baseline/Pretreatment Mild	0 Percentage of Participants	3.7 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Tongue at Day 1 - Baseline/Pretreatment Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Tongue at Day 1 - Baseline/Pretreatment Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 1 - Baseline/Pretreatment

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=27 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 1 - Baseline/Pretreatment None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 1 - Baseline/Pretreatment Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 1 - Baseline/Pretreatment Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 1 - Baseline/Pretreatment Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 1 - Baseline/Pretreatment

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=27 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 1 - Baseline/Pretreatment None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 1 - Baseline/Pretreatment Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 1 - Baseline/Pretreatment Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 1 - Baseline/Pretreatment Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 1 - Post-treatment

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 1 - Post-treatment None	96.2 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 1 - Post-treatment Mild	3.8 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 1 - Post-treatment Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 1 - Post-treatment Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 1 - Post-treatment

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 1 - Post-treatment None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 1 - Post-treatment Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 1 - Post-treatment Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 1 - Post-treatment Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 1 - Post-treatment

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 1 - Post-treatment None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 1 - Post-treatment Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 1 - Post-treatment Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 1 - Post-treatment Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 1 - Post-treatment

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 1 - Post-treatment None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 1 - Post-treatment Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 1 - Post-treatment Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 1 - Post-treatment Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 1 - Post-treatment

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Gingiva at Day 1 - Post-treatment None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Gingiva at Day 1 - Post-treatment Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Gingiva at Day 1 - Post-treatment Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Gingiva at Day 1 - Post-treatment Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 1 - Post-treatment

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Tongue at Day 1 - Post-treatment None	96.2 Percentage of Participants	96.3 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Tongue at Day 1 - Post-treatment Mild	3.8 Percentage of Participants	3.7 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Tongue at Day 1 - Post-treatment Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Tongue at Day 1 - Post-treatment Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 1 - Post-treatment

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 1 - Post-treatment None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 1 - Post-treatment Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 1 - Post-treatment Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 1 - Post-treatment Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 1 - Post-treatment

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 1 - Post-treatment None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 1 - Post-treatment Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 1 - Post-treatment Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 1 - Post-treatment Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 3

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 3 None	96.2 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 3 Mild	3.8 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 3 Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 3 Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 3

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 3 None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 3 Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 3 Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 3 Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 3

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 3 None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 3 Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 3 Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 3 Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 3

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 3 None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 3 Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 3 Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 3 Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 3

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Gingiva at Day 3 None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Gingiva at Day 3 Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Gingiva at Day 3 Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Gingiva at Day 3 Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 3

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Tongue at Day 3 Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Tongue at Day 3 None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Tongue at Day 3 Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Tongue at Day 3 Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 3

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 3 Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 3 None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 3 Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 3 Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 3

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 3 Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 3 Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 3 None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 3 Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 5

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=25 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 5 Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 5 None	96.0 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 5 Mild	4.0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 5 Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 5

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=25 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 5 Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 5 None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 5 Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 5 Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 5

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=25 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 5 None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 5 Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 5 Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 5 Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 5

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=25 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 5 None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 5 Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 5 Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 5 Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 5

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=25 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Gingiva at Day 5 None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Gingiva at Day 5 Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Gingiva at Day 5 Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Gingiva at Day 5 Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 5

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=25 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Tongue at Day 5 Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Tongue at Day 5 None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Tongue at Day 5 Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Tongue at Day 5 Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 5

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=25 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 5 None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 5 Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 5 Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 5 Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 5

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=25 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 5 None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 5 Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 5 Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 5 Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 24 - Pretreatment

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=23 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 24 - Pretreatment None	100 Percentage of Participants	96.3 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 24 - Pretreatment Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 24 - Pretreatment Moderate	0 Percentage of Participants	3.7 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 24 - Pretreatment Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 24 - Pretreatment

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=23 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 24 - Pretreatment None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 24 - Pretreatment Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 24 - Pretreatment Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 24 - Pretreatment Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 24 - Pretreatment

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=23 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 24 - Pretreatment None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 24 - Pretreatment Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 24 - Pretreatment Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 24 - Pretreatment Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 24 - Pretreatment

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=23 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 24 - Pretreatment Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 24 - Pretreatment None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 24 - Pretreatment Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 24 - Pretreatment Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 24 - Pretreatment

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=23 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Gingiva at Day 24 - Pretreatment Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Gingiva at Day 24 - Pretreatment None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Gingiva at Day 24 - Pretreatment Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Gingiva at Day 24 - Pretreatment Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 24 - Pretreatment

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=23 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Tongue at Day 24 - Pretreatment None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Tongue at Day 24 - Pretreatment Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Tongue at Day 24 - Pretreatment Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Tongue at Day 24 - Pretreatment Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 24 - Pretreatment

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=23 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 24 - Pretreatment None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 24 - Pretreatment Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 24 - Pretreatment Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 24 - Pretreatment Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 24 - Pretreatment

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=23 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=27 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 24 - Pretreatment None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 24 - Pretreatment Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 24 - Pretreatment Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 24 - Pretreatment Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 24 - Post-treatment

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=23 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=26 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 24 - Post-treatment None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 24 - Post-treatment Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 24 - Post-treatment Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 24 - Post-treatment Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 24 - Post-treatment

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=23 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=26 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 24 - Post-treatment None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 24 - Post-treatment Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 24 - Post-treatment Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 24 - Post-treatment Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 24 - Post-treatment

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=23 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=26 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 24 - Post-treatment None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 24 - Post-treatment Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 24 - Post-treatment Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 24 - Post-treatment Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 24 - Post-treatment

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=23 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=26 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 24 - Post-treatment Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 24 - Post-treatment None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 24 - Post-treatment Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 24 - Post-treatment Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 24 - Post-treatment

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=23 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=26 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Gingiva at Day 24 - Post-treatment Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Gingiva at Day 24 - Post-treatment None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Gingiva at Day 24 - Post-treatment Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Gingiva at Day 24 - Post-treatment Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 24 - Post-treatment

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=23 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=26 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Tongue at Day 24 - Post-treatment None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Tongue at Day 24 - Post-treatment Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Tongue at Day 24 - Post-treatment Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Tongue at Day 24 - Post-treatment Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 24 - Post-treatment

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=23 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=26 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 24 - Post-treatment None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 24 - Post-treatment Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 24 - Post-treatment Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 24 - Post-treatment Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 24 - Post-treatment

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=23 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=26 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 24 - Post-treatment None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 24 - Post-treatment Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 24 - Post-treatment Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 24 - Post-treatment Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 25

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=23 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=26 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 25 None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 25 Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 25 Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 25 Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 25

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=23 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=26 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 25 None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 25 Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 25 Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 25 Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 25

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=23 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=26 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 25 None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 25 Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 25 Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 25 Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 25

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=23 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=26 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 25 None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 25 Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 25 Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 25 Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 25

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=23 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=26 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Gingiva at Day 25 None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Gingiva at Day 25 Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Gingiva at Day 25 Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Gingiva at Day 25 Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 25

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=23 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=26 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Tongue at Day 25 None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Tongue at Day 25 Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Tongue at Day 25 Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Tongue at Day 25 Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 25

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=23 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=26 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 25 Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 25 None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 25 Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 25 Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 25

Population: Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

Outcome measures

Measure	12027-020 n=23 Participants 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)	19292-116-A Control (Listerine®) n=26 Participants Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)	12027-019 n=26 Participants 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 25 None	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 25 Mild	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 25 Moderate	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 25 Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

Adverse Events

19292-116-A Control (Listerine®)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

12027-019

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

12027-020

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Lynch, DMD, PhD/Study Director

Johnson & Johnson Consumer and Personal Products Worldwide

Phone: 908-433-6423 USA EST

Email: mlynch23@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee Principal investigator agreed not to publish the study results without prior sponsor approval.
• Publication restrictions are in place

Restriction type: OTHER