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 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 two-tailed 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).

Keywords: biofilm(s); drug delivery; oral hygiene; salivary antimicrobial proteins.

Figure 1

Schematic of the 4‐day plaque regrowth study design

Figure 2

General procedures completed per visit over the course of the study

Figure 3

Study subjects that participated in the clinical trial. (a) Inclusion and exclusion criteria applied in the selection of the study subjects. (b) Study subjects demographics according to treatment arm

Figure 4

Quigley–Hein Turesky (QHT) plaque index scores for the whole mouth or subsections of the mouth. (a) QHT plaque index scores in each study arm for Day 0 (baseline) and Day 4. (b) The number represented in the first two columns is the plaque index score at baseline (Day 0) minus plaque index score at reevaluation (Day 4). Larger numbers represent a greater inhibition of plaque regrowth during the 4 days of the study

Figure 5

Data plot of each study subject per treatment arm. Comparison of the difference in the mean whole mouth plaque index score at baseline (Day 0) minus plaque index score at reevaluation (day 4) versus the mean whole mouth plaque index score at baseline (Day 0). Two outliers are represented by 01–014 and 01–024