Clinical Investigation to Examine Toothpaste Effect on Oral Bacteria
Condition: Oral Bacteria Levels in the Mouth
Intervention: Total Flavor option 1; Total Flavor option 2; Placebo toothpaste: Crest Cavity Protection toothpaste
Intervention description: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1; Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2; Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 128.0
Sex: All
Minimum age: 22 Years
Maximum age: 58 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective was to evaluate the antibacterial effects of two toothpastes containing
      0.3% triclosan, 2% copolymer and 0.234% sodium fluoride in a silica base as compared to a
      control regular fluoride toothpaste on anaerobic and malodor bacteria 12 hours after 13 days
      of product use. A secondary objective was to demonstrate that a toothpaste containing 0.3%
      triclosan, 2% copolymer, 0.234% sodium fluoride and a flavor with odor-masking ingredients in
      silica base (Colgate Total Toothpaste-Flavor Option 1) provides a level of antibacterial
      efficacy that is "equivalent" to a toothpaste containing 0.3% triclosan, 2% copolymer, 0.234%
      sodium fluoride and a regular flavor in silica base (Colgate Total Toothpaste-Flavor Option
      2) after 13 days of product use.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females in good general health aged 18 to 70 years.

          2. A willingness to read, understand, and sign the Informed Consent Form after the nature
             of the study has been fully explained to them. Subject should demonstrate a
             willingness to comply with all study procedures and sampling schedules.

          3. A minimum of 20 natural teeth with facial and lingual scorable surfaces.

          4. Adequate oral hygiene and no signs of oral neglect.

          5. Good periodontal health. Enrolled subjects will have no more than five periodontal
             pockets of 5 mm.

          6. Subjects with gingival index greater than or equal to 1.0 (Loe-Silness Index) and
             plaque index greater than or equal to 1.5 (Turesky modification of Quigley-Hein Index)
             will be enrolled.

        Exclusion Criteria:

          1. History of significant adverse effects following use of oral hygiene products such as
             toothpastes and mouthrinses. Allergy to personal care/consumer products or their
             ingredients.

          2. Teeth that are grossly carious, fully crowned or extensively restored on facial and/or
             lingual surfaces, orthodontically banded, abutments, or third molars

          3. History of diabetes or hepatic or renal disease, or other serious medical conditions
             or transmittable diseases, e.g. heart disease or AIDS.

          4. History of rheumatic fever, heart murmur, mitral valve prolapse or other conditions
             requiring prophylactic antibiotic coverage prior to invasive dental procedures.

          5. Subjects on antibiotic, anti-inflammatory or anticoagulant therapy during the month
             preceding the baseline exam.

          6. Significant oral soft tissue pathology, systemically related gingival enlargement,
             severe gingivitis (based on a visual examinations).

          7. History of active severe periodontal disease with bleeding gums and loose teeth.

          8. Gross dental caries, severe generalized cervical abrasion and/or enamel abrasion,
             large fractured or temporary restorations (based on visual examinations).will not be
             included in the tooth count.

          9. Fixed or removable orthodontic appliance or removable partial dentures.

         10. Participation in a dental plaque/gingivitis clinical study involving oral care
             products, within the last 30 days. History of dental prophylaxis or treatments in the
             past month.

         11. Self reported pregnancy or lactation.

         12. History or current use of objects to pierce the lips or tongue.

         13. Subjects known to be an alcoholic, or a recovering alcoholic.

         14. History or current use of recreational drugs.