Trial Outcomes & Findings for Effectiveness of Two Water-Based Potassium Oxalate Desensitizers on Dental Hypersensitivity (NCT NCT02152826)

Last Updated: 2020-09-18

Results Overview

The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The mean change from Baseline was calculated for this measure.

Recruitment status

COMPLETED

Study phase

Target enrollment

80 participants

Primary outcome timeframe

36 days

Results posted on

2020-09-18

Participant Flow

Participant milestones

Participant milestones
Measure	Potassium Oxalate Gel Professional application Potassium oxalate: Professional application	Potassium Oxalate Liquid Professional application Potassium oxalate: Professional application
Overall Study STARTED	45	35
Overall Study COMPLETED	44	34
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness of Two Water-Based Potassium Oxalate Desensitizers on Dental Hypersensitivity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Potassium Oxalate Gel n=45 Participants Professional application Potassium oxalate: Professional application	Potassium Oxalate Liquid n=35 Participants Professional application Potassium oxalate: Professional application	Total n=80 Participants Total of all reporting groups
Age, Continuous	46.7 years STANDARD_DEVIATION 13.26 • n=5 Participants	45.7 years STANDARD_DEVIATION 13.72 • n=7 Participants	46.3 years STANDARD_DEVIATION 13.39 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	20 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	15 Participants n=7 Participants	37 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Asian Indian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Asian Oriental	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Black	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Caucasian	22 Participants n=5 Participants	16 Participants n=7 Participants	38 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Multi-Racial	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 36 days

Population: Eighty (80) subjects received study products. Seventy-eight (78) subjects completed the study. Two subjects dropped from the study after the Day 6 visit.

Outcome measures

Outcome measures
Measure	Potassium Oxalate Gel n=44 Participants Professional application Potassium oxalate: Professional application	Potassium Oxalate Liquid n=34 Participants Professional application Potassium oxalate: Professional application
Change From Baseline for Air Challenge	-1.18 units on a scale Standard Error 0.46	-1.10 units on a scale Standard Error 0.56

SECONDARY outcome

Timeframe: 36 days

Population: Eighty (80) subjects received product. Seventy-eight (78) subjects completed the study. Two subjects dropped from the study after the Day 6 visit.

Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced.

Outcome measures

Outcome measures
Measure	Potassium Oxalate Gel n=44 Participants Professional application Potassium oxalate: Professional application	Potassium Oxalate Liquid n=34 Participants Professional application Potassium oxalate: Professional application
Change From Baseline in Dentin Sensitivity Schiff Air Index	-1.18 untis on a scale Standard Error 0.46	-1.10 untis on a scale Standard Error 0.56
Change From Baseline in Dentin Sensitivity Visual Analog Scale	-27.18 untis on a scale Standard Error 21.10	-30.57 untis on a scale Standard Error 18.16

Adverse Events

Potassium Oxalate Gel

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Potassium Oxalate Liquid

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Potassium Oxalate Gel n=45 participants at risk Professional application Potassium oxalate: Professional application	Potassium Oxalate Liquid n=35 participants at risk Professional application Potassium oxalate: Professional application
Gastrointestinal disorders Stomatitis	2.2% 1/45 • 36 days	0.00% 0/35 • 36 days
Gastrointestinal disorders Tongue coated	2.2% 1/45 • 36 days	0.00% 0/35 • 36 days
Infections and infestations Gingival abscess	0.00% 0/45 • 36 days	2.9% 1/35 • 36 days

Additional Information

Clinical Trial Manager

The Procter & Gamble Company

Phone: 513-622-2489

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Written consent from Sponsor
Publication restrictions are in place

Restriction type: OTHER