NCT01877421

Safety and Tolerability of Antiplaque Chewing Gum in a Gingivitis Population

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is a Phase 1/2a placebo-controlled, double-blind, randomized, dose-escalation study to evaluate the safety and proof of concept of Antiplaque Chewing Gum. This is a 2-part trial with 9 dosing cohorts in Phase 1 and 7 dosing cohorts in Phase 2a. For both phases, the oral soft (OST) and oral hard tissues (OHT) will be examined. Changes from baseline, such as soft tissue erythema, ulceration and sloughing, will be noted and assessments will be made by the principal investigator as to whether they might be attributable to the antiplaque chewing gum. In the Phase 2a portion of the study, the efficacy of the antiplaque chewing gum in reducing existing supragingival plaque and gingivitis will also be assessed. Plaque will be assessed using the Turesky Modification of the Quigley-Hein Plaque Index (PI, Turesky et al-1970) and gingivitis will be assessed using both the Modified Gingival Index (MGI, Lobene et al-1986) and the percent of bleeding sites on gentle probing (BOP) using the methods described in Ainamo and Bay-1975.

Conditions

• Plaque
• Gingivitis

Interventions

Type	Name	Description
DRUG	2 mg KSL-W
DRUG	4 mg KSL-W
DRUG	6 mg KSL-W
DRUG	10 mg KSL-W
DRUG	20 mg KSL-W
DRUG	30 mg KSL-W
DRUG	50 mg KSL-W
DRUG	75 mg KSL-W
DRUG	100 mg KSL-W
OTHER	Placebo	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.

Timeline

• Start date: 2014-02-25
• Primary completion: 2015-08-25
• Completion: 2016-03-01
• First posted: 2013-06-13
• Last updated: 2020-02-13
• Results posted: 2017-09-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study