Clinical Study Comparing Dental Plaque and Gingivitis Reduction After Using One of Three Oral Hygiene Multi-component Regimens (Using of a Manual Toothbrush, a Toothpaste and a Mouthwash)
Condition: Dental Plaque; Gingivitis
MeSH terms: Gingivitis; Dental Plaque
Intervention: Triclosan/fluoride toothpaste; stannous fluoride toothpaste; fluoride only toothpaste; Cetylpyridinium chloride mouthwash; Fluoride only mouthwash
Intervention description: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration).; Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).; Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.; Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds.; Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds.
Intervention MeSH terms: Triclosan; Cetylpyridinium; Fluorides; Tin Fluorides
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 179.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of this clinical research study is to assess the efficacy of a commercially
      available triclosan/copolymer toothpaste compared to a commercially available oral hygiene
      multi-component regimen encompassing the use of a manual toothbrush, a toothpaste containing
      stannous fluoride / sodium hexametaphosphate and a mouthwash containing cetylpyridinium
      chloride relative to a negative control regimen in reducing established dental plaque and
      gingivitis over three and six months of assigned product use.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female subjects, ages 18-70, inclusive.

          2. Availability for the six-month duration of the study.

          3. Good general health.

          4. Minimum of 20 uncrowned permanent natural teeth (excluding third molars).

          5. Initial gingivitis index of at least 1.0 as determined by the use of the Loe and
             Silness Gingival Index.

          6. Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein
             Plaque Index (Turesky Modification).

          7. Signed Informed Consent Form.

        Exclusion Criteria:

          1. Presence of orthodontic bands.

          2. Presence of partial removable dentures.

          3. Tumor(s) of the soft or hard tissues of the oral cavity.

          4. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss
             of periodontal attachment or alveolar bone).

          5. Five or more carious lesions requiring immediate restorative treatment.

          6. Use of antibiotics any time during the one month prior to entry into the study.

          7. Participation in any other clinical study or test panel within the one month prior to
             entry into the study.

          8. Pregnant women or women who are breast feeding.

          9. Dental prophylaxis received in the past two weeks prior to baseline examinations.

         10. History of allergies to oral care/personal care consumer products or their
             ingredients.

         11. On any prescription medicines that might interfere with the study outcome.

         12. An existing medical condition which prohibits eating or drinking for periods up to 4
             hours.

         13. History of alcohol or drug abuse