Clinical Investigation of the Effects of Colgate Total Toothpaste as Compared to a Matching Placebo on Periodontal Disease and Systemic Inflammatory Markers

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single center, double blinded, randomized, controlled trial. Qualified subjects will be enrolled and randomized to either one of the two study groups: a) using 0.3% triclosan/copolymer/fluoride dentifrice twice daily - b) using a matching control dentifrice (copolymer/fluoride/no triclosan) twice daily.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

Criteria

Inclusion Criteria:

1. Subject males or females 18 to 50 years old.

2. Availability for the 12 months duration of the clinical research study.

3. Subject able and willing to follow study procedures and instructions.

4. Subject read, understood and signed an informed consent form.

5. Subject present with at least 20 natural teeth in the functional dentition (excluding third molars).

6. Initial probing pocket depth of >4mm in at least one tooth/quadrant.

7. Good general health.

8. Subjects willing to disclose information on medication.

Exclusion Criteria:

1. Subject with concomitant periodontal therapy 6 months prior to enrollment.

2. Subject with orthodontic appliances.

3. Subject chronically treated (i.e. two weeks or more) with any medication known to affect inflammation or periodontal status or within one month of the first examination*.

4. Subject treated with antibiotics within 3 months prior to enrollment.

5. Subject necessitating antibiotic prophylaxis.

6. Subject with active infectious diseases (hepatitis, human immunodeficiency virus or Tuberculosis) or subject is immunocompromised as determined by the Investigator*.

7. Subject with known allergy to oral care products or ingredients in oral care products.

8. Subject with gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque and calculus, or soft or hard tissue tumor of the oral cavity (determined by the examiner).

9. Subject diagnosed with aggressive periodontitis or acute necrotizing ulcerative gingivitis.

10. Participation in any other clinical study or test panel within the one month prior to entry into the study.

11. Subject pregnant at point of enrollment.