The Clinical Efficacy of Three Oral Hygiene Regimens Using a Manual Toothbrush, Toothpaste and a Mouthwash in Controlling Dental Plaque and Gingivitis
Condition: Dental Plaque; Gingivitis
MeSH terms: Gingivitis; Dental Plaque
Intervention: triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash; stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash; fluoride toothpaste + fluoride Mouthwash
Intervention description: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.; Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.; Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.
Intervention MeSH terms: Triclosan; Cetylpyridinium; Fluorides; Tin Fluorides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 120.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of this clinical research study is to assess the efficacy of three oral hygiene
      multi-component regimens encompassing the use of a manual toothbrush, toothpaste and a
      mouthwash in controlling established dental plaque and gingivitis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female subjects, ages 21-70, inclusive.

          2. Availability for the six-week 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