Cetylpyridium Chloride (CPC) Based Chewing Gum and Gingivitis

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Periodontal Diseases; Plaque, Dental; Gingivitis

Treatments: Drug: Xylitol only chewing gum; Drug: Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum

Study type: Interventional

Funder types: Other

Identifiers

NCT03219840

HSC-DB-17-0313

Details and patient eligibility

About

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).

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups

CPC + Xylitol chewing gum, then Xylitol only chewing gum

Experimental group

Description:

Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum and then Xylitol only chewing gum All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated. Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum will be used for the first 21 days, then there will be a washout period of 21 days, and finally Xylitol only chewing gum will be used for the last 21 days.

Treatment:

Drug: Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum

Drug: Xylitol only chewing gum

Xylitol only chewing gum, then CPC + Xylitol chewing gum

Experimental group

Description:

Xylitol only chewing gum and then 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. Xylitol only chewing gum will be used for the first 21 days, then there will be a washout period of 21 days, and finally Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum will be used for the last 21 days.

Treatment:

Drug: Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum

Drug: Xylitol only chewing gum