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

NCT ID: NCT02670135

Last Updated: 2019-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 303 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-08-31

Brief 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.

Detailed Description

The objective of this study is to comparatively evaluate the effects of Colgate Total® toothpaste with triclosan (commercially sold in Israel) and triclosan-free matching placebo toothpaste on markers of inflammation in the bloodstream and to correlate these findings with periodontal disease status in the oral cavity, as determined by the parameters assessed. Periodontal parameters (periodontal pocket dept (PPD), Clinical Attachment loss (CAL)) will be assessed at baseline and after 2, 6 and 12 months of product use. Peripheral blood samples will be drawn from the subjects at baseline and after 2, 6 and 12 months to evaluate the effects of tooth brushing on systemic inflammatory markers (CRP, PGE2, IL-1β, TNF-α).

Conditions

Periodontal Disease; Systemic Inflammatory Markers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

triclosan free toothpaste

Control toothpaste with no triclosan ingredients in a 1450 ppm sodium fluoride/silica base - matching placebo

Group Type: PLACEBO_COMPARATOR

Triclosan Free Toothpaste

Intervention Type: DRUG

Control toothpaste with no triclosan ingredients in a 1450 ppm sodium fluoride/silica base - matching placebo

Triclosan containing toothpaste

Active formula containing 0.3% triclosan in a1450 ppm sodium fluoride/silica base

Group Type: ACTIVE_COMPARATOR

Triclosan Containing Toothpaste

Intervention Type: DRUG

Active formula containing 0.3% triclosan in a1450 ppm sodium fluoride/silica base

Interventions

Triclosan Containing Toothpaste

Active formula containing 0.3% triclosan in a1450 ppm sodium fluoride/silica base

Intervention Type: DRUG

Triclosan Free Toothpaste

Control toothpaste with no triclosan ingredients in a 1450 ppm sodium fluoride/silica base - matching placebo

Intervention Type: DRUG

Other Intervention Names

Active comparator; Total Toothpaste; Control toothpaste

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Colgate Palmolive

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CRO-2014-09-CT-ISR-DB

Identifier Type: -

Identifier Source: org_study_id