NCT02670135

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 303 (actual)
• Sponsor: Colgate Palmolive · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Triclosan Containing Toothpaste	Active formula containing 0.3% triclosan in a1450 ppm sodium fluoride/silica base
DRUG	Triclosan Free Toothpaste	Control toothpaste with no triclosan ingredients in a 1450 ppm sodium fluoride/silica base - matching placebo

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-07-01
• Completion: 2016-08-01
• First posted: 2016-02-01
• Last updated: 2019-02-22