Authors: Brian Kirkwood, Michael Miller, Jeffery Milleman, Kimberly Milleman
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 duration of the trial.
Twelve to 16 hr prior to the baseline visit, the subjects were to abstain from oral
hygiene care. The Quigley–Hein Turesky plaque index (QHT) score and the oral soft
tissue clinical exams were obtained at both Day 0 and Day 4.
Results: All randomized study subjects that received either APCG or placebo gum
completed the study with no significant adverse events recorded. The APCG significantly
inhibited the regrowth of dental plaque over the course of 4 days. The whole
mouth data demonstrated a difference in the QHT between the APCG and the placebo
gum of 1.14 (SE = 0.27) and 95% confidence bounds of 0.58, 1.70 with a twotailed
P value of .0003.
Conclusion: Considering the limited sample size, the proof of concept analysis in this
Phase 2 study confirmed that APCG is effective against dental plaque formation and
safe for human use. (ClinicalTrials.gov Study ID# NCT02864901).