Four-day plaque regrowth evaluation of a peptide chewing gum in a double-blind randomized clinical trial.

ABSTRACT:

Objective

Antimicrobial peptide, KSL-W, formulated as an antiplaque chewing gum (APCG), was tested to evaluate the dental plaque inhibition activity and safety in an IRB approved and FDA regulated 4-day plaque regrowth clinical study.

Methods

This Phase 2 two-armed placebo-controlled, double blind, randomized (1:1), multiple dose, and single-center study was evaluated in a proof of concept for the APCG containing 30 mg antimicrobial peptide KSL-W. Twenty six generally healthy subjects were consented and randomized into the study. The subjects were administered a dose three times per day for four treatment days following a complete dental prophylaxis. Participants were prohibited from conducting oral hygiene care (teeth brushing, flossing, and/or mouth wash rinse) for the dur

SUBMITTER: Kirkwood B 

PROVIDER: S-EPMC7301399 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature