At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effects of Cetylpyridium Chloride (CPC) Based Chewing Gum Plus Tooth Brushing on Plaque Formation and Gingivitis: a Randomized, Double-Blind, Crossover, Placebo-controlled Clinical Trial
In Brief
A Phase 4 clinical trial evaluating Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum and Xylitol only chewing gum for Gingivitis and 2 related conditions. Completed, enrolled 70 participants across 1 site.
Detailed Summary
This placebo-controlled, double-blinded, randomized crossover study evaluates the plaque and gingivitis reducing capacity of Cetylpyridium Chloride (CPC) chewing gum, with mechanical oral hygiene. The study will enroll 73 students, faculty, and staff from the UTHealth School of Dentistry. Half of the eligible participants will be randomly assigned to get the CPC gum in the first treatment period (21 days), a wash-out period of 21 days, and then a placebo gum in the second treatment period (21 days). The other half will be assigned to follow the same schedule but with the treatment reversed. A statistician will perform the randomization. Primary outcomes are assessed by validated tools, such as the Plaque Index (PI), Gingival Index (GI), and percent of bleeding sites on probe (BOP).
Study Details
Timeline
Interventions
All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.
All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.