At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 135 enrolled
Drug / intervention
2 mg KSL-W +9 moredrug
Likely dose
2 mg KSL-Wfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-Blind, Randomized, Controlled, Dose Escalation Clinical Trial of an Antiplaque Chewing Gum - Phase 1 Safety and Tolerability and Phase 2a Safety, Tolerability, and Proof of Concept in a Gingivitis Population
U.S. Army Medical Research and Development Command·interventional·Posted Jun 13, 2013·Updated Feb 13, 2020
In Brief
A Phase 2 clinical trial evaluating 2 mg KSL-W, 4 mg KSL-W, and 8 other interventions for Plaque and Gingivitis. Completed, enrolled 135 participants across 1 site.
Detailed Summary
This study is to assess the safety and tolerability of single doses and multiple doses in reducing plaque and gingivitis when delivered in a chewing gum formulation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPlaque, Gingivitis
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 2013
Enrollment StartFeb 2014
Primary CompletionAug 2015
Study CompletionMar 2016
TodayJul 2026
First PostedJun 13, 2013
Enrollment StartFeb 25, 2014
Primary CompletionAug 25, 2015
Study CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 13.1 years ago
Interventions
2 mg KSL-Wdrug
4 mg KSL-Wdrug
6 mg KSL-Wdrug
10 mg KSL-Wdrug
20 mg KSL-Wdrug
30 mg KSL-Wdrug
50 mg KSL-Wdrug
75 mg KSL-Wdrug
100 mg KSL-Wdrug
Placeboother
Cetylpyridinium chloride (CPC) as an additive, isomalt as a bulk sweetener, peppermint powder for flavoring, sucralose as an intense sweetener, colloidal silicon dioxide is a flow enhancer, magnesium stearate as a process aid, and the proprietary gum base formulation.