Safety and Tolerability of Antiplaque Chewing Gum in a Gingivitis Population

Phase 1/2 Completed 135 enrolled U.S. Army Medical Research and Development Command

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2014-02-25
Primary completion: 2015-08-25
Completion: 2016-03

Publications

Ryan JB, Kirkwood BJ, Leung KP. Combined Phase 1/2a Initial Clinical Safety Trials and Proof-of-Concept Assessment of a Novel Antimicrobial Peptide KSL-W Anti-Plaque Chewing Gum. Clin Exp Dent Res. 2024 Dec;10(6):e943. doi: 10.1002/cre2.943.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	KSL-W	Peptide	2 mg	Oral
Subject	KSL-W	Peptide	4 mg	Oral
Subject	KSL-W	Peptide	6 mg	Oral
Subject	KSL-W	Peptide	10 mg	Oral
Subject	KSL-W	Peptide	20 mg	Oral
Subject	KSL-W	Peptide	30 mg	Oral
Subject	KSL-W	Peptide	50 mg	Oral
Subject	KSL-W	Peptide	75 mg	Oral
Subject	KSL-W	Peptide	100 mg	Oral

Safety and Tolerability of Antiplaque Chewing Gum in a Gingivitis Population

Summary

Timeline

Publications

Drugs

Indications