The Clinical Investigation of Toothpaste as Compared to Toothpaste and Mouthwash in Reducing Plaque and Gingivitis: A Six-week Clinical Study in the US
Condition: Dental Plaque; Gingivitis
MeSH terms: Gingivitis; Dental Plaque
Intervention: Triclosan/fluoride toothpaste; stannous fluoride toothpaste; fluoride toothpaste; Fluoride Mouthwash; cetylpyridinium chloride Mouthwash
Intervention description: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (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 weeks (study duration).; Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration).; Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time.; Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time.
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: 129.0
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 evaluate clinical efficacy of Colgate
      Total Toothpaste as compared to Crest Pro-Health Toothpaste and Crest Pro-Health Mouthwash,
      and Crest Cavity Protection Toothpaste and Crest Fluoride Mouthwash in reducing gingivitis
      and dental plaque in adults in a six-week clinical study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects, ages 18-70, inclusive.

          2. Availability for the six-week duration of the clinical research 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. Antibiotic use 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. Dental prophylaxis during the past two weeks prior to baseline examinations.

          9. History of allergies to oral care/personal care consumer products or their
             ingredients.

         10. On any prescription medicines that might interfere with the study outcome.

         11. An existing medical condition which prohibits eating or drinking for periods up to 4
             hours.

         12. History of alcohol or drug abuse.

         13. Pregnant or lactating subjects.