NCT03219840

Cetylpyridium Chloride (CPC) Based Chewing Gum and Gingivitis

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Conditions

• Gingivitis
• Plaque, Dental
• Periodontal Diseases

Interventions

Type	Name	Description
DRUG	Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum	All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.
DRUG	Xylitol only chewing gum	All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.

Timeline

• Start date: 2017-10-18
• Primary completion: 2018-09-08
• Completion: 2018-09-08
• First posted: 2017-07-18
• Last updated: 2021-02-08
• Results posted: 2021-02-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study