NCT02864901

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

A Double-Blind, Randomized, Placebo Controlled, Clinical Trial of an Antiplaque Chewing Gum (30 mg) - Phase 2 Proof of Concept in a Generally Healthy Patient Population

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

The Safety, efficacy and tolerability of an Antimicrobial Chewing Gum Formulation in Reducing Dental Plaque

Detailed description

A Phase 2 two-armed placebo-controlled, double-blind, randomized (1:1), multiple dose, single center interventional study to evaluate the safety and proof of concept for an antimicrobial decapeptide KSL-W chewing gum formulation 3 times per day over 4 treatment days measuring dental plaque regrowth from specific regions of the upper jaw, lower jaw, buccal and lingual surfaces.

Conditions

• Plaque Regrowth

Interventions

Type	Name	Description
DRUG	KSL-W	Antimicrobial KSL-W Plaque reducing chewing gum

Timeline

• Start date: 2016-10-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2016-08-12
• Last updated: 2025-07-15
• Results posted: 2025-07-15