Cetylpyridium Chloride (CPC) Based Chewing Gum and Gingivitis

• Status: Completed
• Trial end date: 2018-09-08
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Collaborator: CONFADENT Oral Technology, Kiss Industries LLC
• Treatments: Cetylpyridinium

Criteria

Inclusion Criteria:

• Be aged 18 and older

• Be capable of giving informed consent themselves and are able and willing to participate in the study

• Patients willing to forgo any optional dental procedures during the study period, such as dental prophylaxis or teeth whitening

• Patients that regularly brush their teeth twice a day

Exclusion Criteria:

• Pregnant or breastfeeding women

• Patients taking long-term anti-microbial or anti-inflammatory drugs

• Patients unable or unwilling to provide informed consent

• Self-reported use of tobacco products

• Gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque or calculus, or soft or hard tissue tumor of the oral cavity

• Less than 26 teeth in the mouth

• Orthodontic appliances or removable partial dentures that will compromise the ability of the potential subject to participate in the study

• Periodontitis as indicated periodontal pockets greater than 5 millimeters on more than one site

• Inability to comply with assigned treatment regimen