Cetylpyridium Chloride (CPC) Based Chewing Gum and Gingivitis
Condition: Gingivitis; Plaque, Dental; Periodontal Diseases
MeSH terms: Gingivitis; Periodontal Diseases; Dental Plaque
Intervention: Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum; Xylitol only chewing gum
Intervention description: All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.; All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.
Intervention MeSH terms: Cetylpyridinium
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A Randomized, Double-blind, Crossover, Placebo-controlled Clinical Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cetylpyridium Chloride (CPC); Chewing Gum

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