Phase 4 N=69 Randomized Quadruple-blind Prevention

Cetylpyridium Chloride (CPC) Based Chewing Gum and Gingivitis

Gingivitis · Plaque, Dental · Periodontal Diseases

Bottom Line

View on ClinicalTrials.gov: NCT03219840 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2021

Primary outcome: Primary: Degree of Plaque as Assessed by the Turesky Modification of the Quigley-Hein Plaque Index — 0.41; 0.43 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum (Drug); Xylitol only chewing gum (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The University of Texas Health Science Center, Houston
Primary completion: Sep 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Degree of Plaque as Assessed by the Turesky Modification of the Quigley-Hein Plaque Index	0.36; 0.35	—
PRIMARY Degree of Plaque as Assessed by the Turesky Modification of the Quigley-Hein Plaque Index	0.36; 0.35	—
PRIMARY Degree of Gingivitis as Assessed by the Gingival Index (GI)	0.21; 0.15	—
PRIMARY Degree of Gingivitis as Assessed by the Gingival Index (GI)	0.21; 0.15	—
PRIMARY Degree of Gingival Bleeding as Assessed by the Bleeding on Probing (BOP) Index	0.08; 0.09	—
PRIMARY Degree of Gingival Bleeding as Assessed by the Bleeding on Probing (BOP) Index	0.08; 0.09	—
SECONDARY Discoloration of Teeth as Assessed by the Vita Scale	25; 27; 24; 22; 3; 2	—
SECONDARY Discoloration of Teeth as Assessed by the Vita Scale	25; 27; 24; 22; 3; 2	—

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).

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03219840). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.