Clinical Study to Evaluate the Treatment of Gingivitis of Two Toothpastes
Condition: Dental Plaque
MeSH terms: Gingivitis; Dental Plaque
Intervention: Fluoride; Triclosan; Fluoride
Intervention description: Brush teeth two times daily for 6 weeks; Brush two times daily for 6 weeks; Brush two times daily for 6 weeks
Intervention MeSH terms: Triclosan; Fluorides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective is to compare two commerical oral products for the treatment of gingivitis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female volunteers 18-65 years of age

          2. Good general health

          3. Must sign informed consent form

          4. Minimum of 16 natural uncrowned teeth (excluding third molars) must be present.

          5. No history of allergy to personal care consumer products, or their ingredients,
             relevant to any ingredient in the test products as determined by the dental/medical
             professional monitoring the study.

          6. Dental Selection Criteria: Gingivitis patients with a minimum of 16 gradable teeth
             with a minimum of 6 sites with a GI score of ≥ 3. Subjects will be stratified
             according to gingivitis severity. Average full mouth GI score should be in the range
             of 2.0 - 2.5. heavy plaque formers should be avoided. Target a full mouth PI
             (Quigley-Hein) to be in the range of 1.5-3.0

        Exclusion Criteria:

          1. Subjects unable or unwilling to sign the informed consent form.

          2. Medical condition which requires pre-medication prior to dental visits/procedures

          3. Moderate or advanced periodontal disease

          4. History of allergy to iodine

          5. History of thyroid disease

          6. History of diabetes

          7. 2 or more decayed untreated dental sites at screening.

          8. Other disease of the hard or soft oral tissues.

          9. Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).

         10. Use of medications that are currently affect salivary flow.

         11. Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.

         12. Pregnant or nursing women.

         13. Participation in any other clinical study within 1 week prior to enrollment into this
             study.

         14. Use of tobacco products

         15. Subjects who must receive dental treatment during the study dates.

         16. Current use of Antibiotics for any purpose.

         17. Presence of an orthodontic appliance.

         18. History of allergy to common dentifrice ingredients

         19. Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)

         20. Women of childbearing potential and not on birth control (Diaphragm, birth control
             pills or implants, IUD (Intrauterine device), condoms).

         21. Smoker