Evaluate Dental Plaque Benefit of a Preventive Treatment Gel
Condition: Dental Plaque
MeSH terms: Dental Plaque
Intervention: Preventive Gel; Marketed Control
Intervention description: 0.4% Stannous Fluoride; 0.243% Sodium Fluoride
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the study is to evaluate anti-plaque efficacy of a preventive treatment gel
      in a modified 4-day plaque model.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide written informed consent prior to participation and be given a signed copy of
             the informed consent form;

          -  Be 18 years of age or older;

          -  Agree not to participate in any other oral/dental product studies during the study;

          -  Agree to delay any elective dentistry (including dental prophylaxis) until the study
             has been completed;

          -  Agree to refrain from the use of any non-study oral hygiene products (subjects who are
             regular flossers will be allowed to floss during acclimation and wash-out periods);

          -  Agree to use an oral hygiene product that contains stannous fluoride;

          -  Agree to refrain from any form of non-specified oral hygiene during the treatment
             period, including the use of products such as floss, toothpicks for plaque removal,
             and chewing gum;

          -  Agree to refrain from any oral hygiene, eating and drinking after 11:00 PM the evening
             before plaque measurements on Day 0 and Day 4 of the treatment periods;

          -  Agree to return for all scheduled visits and follow study procedures;

          -  Possess a minimum of 20 natural teeth with scorable facial and lingual surfaces, of
             which at least 4 are molars; and,

          -  Be in good general health, as determined by the Investigator/designee based on a
             review of the health history/update for participation in the study.

        Exclusion Criteria:• Have a medical condition requiring pre-medication prior to dental
        procedures;

          -  Have taken antibiotics within 2 weeks of the acclimation period or anticipate taking
             antibiotics at any time during the study;

          -  Have a history of allergies or hypersensitivity to dyes or dentifrices that contain
             stannous fluoride;

          -  Have removable or orthodontic appliances which interfere with obtaining 20 gradable
             teeth;

          -  Have previously demonstrated an inability to comply with study visit requirements;

          -  Have rampant caries, open or untreated caries, severe gingivitis or advanced
             periodontitis requiring prompt treatment; or,

          -  Present with any disease or condition(s) that could be expected to interfere with
             examination procedures or the subject's safe completion of the study.