Clinical trial NCT03219840: Cetylpyridium Chloride (CPC) Based Chewing Gum and Gingivitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gingivitis
Plaque, Dental
Periodontal Diseases
Keywords: Cetylpyridium Chloride (CPC)
Chewing Gum
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: CONFADENT Oral Technology, Kiss Industries LLC
First posted: 2017-07-18
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A Randomized, Double-blind, Crossover, Placebo-controlled Clinical Trial
Primary purpose: PREVENTION

Brief 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

Primary outcomes:
measure: Degree of Plaque as Assessed by the Turesky Modification of the Quigley-Hein Plaque Index
timeFrame: day 1
measure: Degree of Plaque as Assessed by the Turesky Modification of the Quigley-Hein Plaque Index
timeFrame: day 22
measure: Degree of Gingivitis as Assessed by the Gingival Index (GI)
timeFrame: day 1
measure: Degree of Gingivitis as Assessed by the Gingival Index (GI)
timeFrame: day 22
measure: Degree of Gingival Bleeding as Assessed by the Bleeding on Probing (BOP) Index
timeFrame: day 1
measure: Degree of Gingival Bleeding as Assessed by the Bleeding on Probing (BOP) Index
timeFrame: day 22
Secondary outcomes:
measure: Discoloration of Teeth as Assessed by the Vita Scale
timeFrame: day 1
measure: Discoloration of Teeth as Assessed by the Vita Scale
timeFrame: day 22
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Flavia Lakschevitz, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: