The Clinical Investigation of a New Toothpaste Containing Stannous Fluoride as Compared to a Commercially Available Fluoride Toothpaste in Reducing Plaque and Gingivitis

• Status: Completed
• Trial end date: 2017-12-07
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to evaluate the clinical efficacy of a new toothpaste containing stannous fluoride (SnF) as compared to Colgate Fluoride Toothpaste in reducing gingivitis and dental plaque.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Colgate Palmolive
• Treatments: Fluorides; Listerine; Sodium Fluoride; Tin Fluorides

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. Self-reported pregnant or lactating subjects.