Trial Outcomes & Findings for Is an Antiplaque Chewing Gum (30 mg) Able to Reduce Dental Plaque in a Healthy Population? (NCT NCT02864901)

Last Updated: 2025-07-15

Results Overview

Day 4 Exam Following 72-hours of Chewing Gum Treatment. Exam Included Vital Signs and Whole Mouth Dental Examination (Maxillary Buccal, Maxillary Lingual, Mandibular Buccal and Mandibular Surfaces) Assessing for Local Oral Mucosal Reactions, Systemic Reactions and Serious Total Body Reactions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

Baseline, and Day 4 Following Three-days of Chewing Gum Treatment

Results posted on

2025-07-15

Participant Flow

Participant milestones

Participant milestones
Measure	KSL-W 30 mg 3 times per day over 4 treatment days KSL-W: Plaque reducing gum	Chewing Gum Placebo 3 times per day over 4 treatment days Chewing Gum Placebo
Overall Study STARTED	14	13
Overall Study COMPLETED	13	13
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	KSL-W 30 mg 3 times per day over 4 treatment days KSL-W: Plaque reducing gum	Chewing Gum Placebo 3 times per day over 4 treatment days Chewing Gum Placebo
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Is an Antiplaque Chewing Gum (30 mg) Able to Reduce Dental Plaque in a Healthy Population?

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline, and Day 4 Following Three-days of Chewing Gum Treatment

Population: 26 Male and female subjects undergoing exam following 72-hours of Chewing Gum Treatment with results compared to baseline

Outcome measures

Outcome measures
Measure	KSL-W 30 mg n=13 Participants 3 times per day over 4 treatment days KSL-W: Plaque reducing gum	Chewing Gum Placebo n=13 Participants 3 times per day over 4 treatment days Placedo Chewing Gum
Safety, Tolerability and Effectiveness in Reducing Dental Plaque of KLS-W Delivered in a Chewing Gum Formulation Local Oral Mucosal Changes	0 participants	0 participants
Safety, Tolerability and Effectiveness in Reducing Dental Plaque of KLS-W Delivered in a Chewing Gum Formulation Systemic Reactions or Serious Total Body Reactions	0 participants	0 participants

SECONDARY outcome

Timeframe: 4 Days

Population: Summary of Quigley-Hein-Turskey Plaque Index Scores, Whole Mouth and by Quadrants baseline (Day 0) and day following 72-hours of treatment (Chewing gum 3x/day)

The Amount of Plaque Regrowth Based on Sub-scores From Specific Regions of the Upper Jaw, Lower Jaw, Buccal and Lingual Surface Based on the Quigley-Hein Turskey Plaque Index (QHT) a measure that evaluates plaque on teeth surfaces on a scale of 0 to 5 defined by Quigley \&Hein in 1962 and modified by Turskey et al in 1970. All teeth except the third molars are assessed. An index for the entire mouth is determined by dividing the total score by the number of surfaces examined. Quigley-Hein-Turskey Plaque Index Scale Minimum score 0=no plaque, 1-Isolated flecks of plaque at the gingival margin, 2=A continuous band of plaque up to 1mm at the gingival margin, 3=Plaque greater than 1mm in width and covering up to one third of the tooth surface, 4=Plaque covering from one thirds to two thirds of the tooth surface, Maximum score of 5=Plaque covering more than two thirds of the tooth surface

Outcome measures

Outcome measures
Measure	KSL-W 30 mg n=13 Participants 3 times per day over 4 treatment days KSL-W: Plaque reducing gum	Chewing Gum Placebo n=13 Participants 3 times per day over 4 treatment days Placedo Chewing Gum
Score on a Scale of Whole Mouth Change in Plaque Regrowth Based on Sub-scores From Specific Regions of the Upper Jaw, Lower Jaw, Buccal and Lingual Surface Using Standardized QHT Measures Whole Mouth Quigley-Hein-Turskey Plaque Score (Day 0)	2.95 QHT Score, Subscore Standard Deviation 0.471	2.96 QHT Score, Subscore Standard Deviation 0.403
Score on a Scale of Whole Mouth Change in Plaque Regrowth Based on Sub-scores From Specific Regions of the Upper Jaw, Lower Jaw, Buccal and Lingual Surface Using Standardized QHT Measures Maxillary Buccal Quigley-Hein-Turskey Plaque Score (Day 0)	3.05 QHT Score, Subscore Standard Deviation 0.712	2.96 QHT Score, Subscore Standard Deviation 0.576
Score on a Scale of Whole Mouth Change in Plaque Regrowth Based on Sub-scores From Specific Regions of the Upper Jaw, Lower Jaw, Buccal and Lingual Surface Using Standardized QHT Measures Maxillary Lingual Quigley-Hein-Turskey Plaque Score (Day 0)	2.52 QHT Score, Subscore Standard Deviation 0.572	2.49 QHT Score, Subscore Standard Deviation 0.434
Score on a Scale of Whole Mouth Change in Plaque Regrowth Based on Sub-scores From Specific Regions of the Upper Jaw, Lower Jaw, Buccal and Lingual Surface Using Standardized QHT Measures Mandibular Buccal Quigley-Hein-Turskey Plaque Score (Day 0)	3.07 QHT Score, Subscore Standard Deviation 0.513	2.80 QHT Score, Subscore Standard Deviation 0.550
Score on a Scale of Whole Mouth Change in Plaque Regrowth Based on Sub-scores From Specific Regions of the Upper Jaw, Lower Jaw, Buccal and Lingual Surface Using Standardized QHT Measures Whole Mouth Quigley-Hein-Turskey Plaque Score (Day 4)	2.80 QHT Score, Subscore Standard Deviation 0.680	1.65 QHT Score, Subscore Standard Deviation 0.725
Score on a Scale of Whole Mouth Change in Plaque Regrowth Based on Sub-scores From Specific Regions of the Upper Jaw, Lower Jaw, Buccal and Lingual Surface Using Standardized QHT Measures Maxillary Buccal Quigley-Hein-Turskey Plaque Score (Day 4)	3.63 QHT Score, Subscore Standard Deviation 0.679	2.85 QHT Score, Subscore Standard Deviation 1.064
Score on a Scale of Whole Mouth Change in Plaque Regrowth Based on Sub-scores From Specific Regions of the Upper Jaw, Lower Jaw, Buccal and Lingual Surface Using Standardized QHT Measures Maxillary Lingual Quigley-Hein-Turskey Plaque Score (Day 4)	1.81 QHT Score, Subscore Standard Deviation 0.558	0.50 QHT Score, Subscore Standard Deviation 0.477
Score on a Scale of Whole Mouth Change in Plaque Regrowth Based on Sub-scores From Specific Regions of the Upper Jaw, Lower Jaw, Buccal and Lingual Surface Using Standardized QHT Measures Mandibular Lingual Quigley-Hein-Turskey Plaque Score (Day 0)	3.20 QHT Score, Subscore Standard Deviation 0.676	3.60 QHT Score, Subscore Standard Deviation 0.663
Score on a Scale of Whole Mouth Change in Plaque Regrowth Based on Sub-scores From Specific Regions of the Upper Jaw, Lower Jaw, Buccal and Lingual Surface Using Standardized QHT Measures Mandibular Buccal Quigley-Hein-Turskey Plaque Score (Day 4)	3.23 QHT Score, Subscore Standard Deviation 0.945	2.16 QHT Score, Subscore Standard Deviation 1.011
Score on a Scale of Whole Mouth Change in Plaque Regrowth Based on Sub-scores From Specific Regions of the Upper Jaw, Lower Jaw, Buccal and Lingual Surface Using Standardized QHT Measures Mandibullar Lingual Quigley-Hein-Turskey Plaque Score (Day 4)	2.52 QHT Score, Subscore Standard Deviation 0.858	1.14 QHT Score, Subscore Standard Deviation 0.779

Adverse Events

KSL-W 30 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Chewing Gum Placebo

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

Emily Badraslioglu, Senior Regulatory Advisor & FDA Sponsor Representative

Office of Regulated Activities

Phone: (301) 619-6828

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	KSL-W 30 mg n=13 Participants 3 times per day over 4 treatment days KSL-W: Plaque reducing gum	Chewing Gum Placebo n=13 Participants 3 times per day over 4 treatment days Chewing Gum Placebo	Total n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants