Overview

This trial is active, not recruiting.

Conditions periodontal disease, systemic inflammatory markers
Treatments triclosan containing toothpaste, triclosan free toothpaste
Phase phase 4
Sponsor Colgate Palmolive
Start date June 2015
End date June 2016
Trial size 303 participants
Trial identifier NCT02670135, CRO-2014-09-CT-ISR-DB

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
Control toothpaste with no triclosan ingredients in a 1450 ppm sodium fluoride/silica base - matching placebo
triclosan free toothpaste Control toothpaste
Control toothpaste with no triclosan ingredients in a 1450 ppm sodium fluoride/silica base - matching placebo
(Active Comparator)
Active formula containing 0.3% triclosan in a1450 ppm sodium fluoride/silica base
triclosan containing toothpaste Active comparator
Active formula containing 0.3% triclosan in a1450 ppm sodium fluoride/silica base

Primary Outcomes

Measure
Periodontal Pocket Depth (PPD)
time frame: baseline
Periodontal Pocket Depth (PPD)
time frame: 2 months
Periodontal Pocket Depth (PPD)
time frame: 6 months
Periodontal Pocket Depth (PPD)
time frame: 12 months
Clinical Attachment Loss (CAL)
time frame: baseline
Clinical Attachment Loss (CAL)
time frame: 2 months
Clinical Attachment Loss (CAL)
time frame: 6 months
Clinical Attachment Loss (CAL)
time frame: 12 months
C Reactive Protein (CRP)
time frame: baseline
C Reactive Protein (CRP)
time frame: 2 months
C Reactive Protein (CRP)
time frame: 6 months
C Reactive Protein (CRP)
time frame: 12 months
Interleukin-1 Beta ( IL-1β)
time frame: baseline
Interleukin-1 Beta (IL-1β)
time frame: 2 months
Interleukin-1 Beta (IL-1β)
time frame: 6 months
Interleukin-1 Beta (IL- 1β)
time frame: 12 months
Tumor necrosis factor - alfa (TNF-α)
time frame: baseline
Tumor necrosis factor - alfa (TNF-α)
time frame: 2 months
Tumor necrosis factor - alfa (TNF-α)
time frame: 6 months
Tumor necrosis factor - alfa (TNF-α)
time frame: 12 months
Prostaglandin E2 (PGE 2)
time frame: baseline
Prostaglandin E2 (PGE 2)
time frame: 2 months
Prostaglandin E2 (PGE 2)
time frame: 6 months
Prostaglandin E2 (PGE 2)
time frame: 12 moths

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

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.

Additional Information

Official title Clinical Investigation of the Effects of Colgate Total Toothpaste as Compared to a Matching Placebo on Periodontal Disease and Systemic Inflammatory Markers
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).
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Colgate Palmolive.