Gingivitis Clinical Trial
Official title:
A Double-Blind, Randomized, Controlled, Dose Escalation Clinical Trial of an Antiplaque Chewing Gum - Phase 1 Safety and Tolerability and Phase 2a Safety, Tolerability, and Proof of Concept in a Gingivitis Population
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.
This study is a Phase 1/2a placebo-controlled, double-blind, randomized, dose-escalation
study to evaluate the safety and proof of concept of Antiplaque Chewing Gum. This is a 2-part
trial with 9 dosing cohorts in Phase 1 and 7 dosing cohorts in Phase 2a. For both phases, the
oral soft (OST) and oral hard tissues (OHT) will be examined. Changes from baseline, such as
soft tissue erythema, ulceration and sloughing, will be noted and assessments will be made by
the principal investigator as to whether they might be attributable to the antiplaque chewing
gum.
In the Phase 2a portion of the study, the efficacy of the antiplaque chewing gum in reducing
existing supragingival plaque and gingivitis will also be assessed. Plaque will be assessed
using the Turesky Modification of the Quigley-Hein Plaque Index (PI, Turesky et al-1970) and
gingivitis will be assessed using both the Modified Gingival Index (MGI, Lobene et al-1986)
and the percent of bleeding sites on gentle probing (BOP) using the methods described in
Ainamo and Bay-1975.
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