The Clinical Investigation of a Zinc Based Toothpaste in Reducing Plaque and Gingivitis
Condition: Dental Plaque and Gingivitis
MeSH terms: Gingivitis; Dental Plaque
Intervention: Control toothpaste; Experimental toothpaste; Active Comparator
Intervention description: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.; 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.; 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 162.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a six (6) month, double-blind, parallel, controlled clinical trial utilizing one
      hundred and sixty (160) adults to evaluate the reduction of dental plaque and gingivitis.
    

Eligibility criteria:

        Inclusion Criteria

          1. Subjects, ages 18-70, inclusive.

          2. Availability for the six-month 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 period 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 that prohibits eating or drinking for periods up to 4
             hours.

         12. History of alcohol or drug abuse.

         13. Pregnant or lactating subjects.