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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary: 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).
Sponsor: Colgate Palmolive

Current Primary Outcome:

  • Periodontal Pocket Depth (PPD) [ Time Frame: baseline ]
    PPD examination will be performed using a World Health Organization (WHO) Community Periodontal Index (CPI) periodontal probe in all teeth present as described by WHO (2013). The PPD examination is according to the pocket scores provided here: 0 = Absence of condition, 1 = Pocket 4-5mm, 2 = Pocket 6mm or more, 9 = Tooth excluded, X = Tooth not present (The lower the number the healthier the tissue)
  • Periodontal Pocket Depth (PPD) [ Time Frame: 2 months ]
    PPD examination will be performed using a World Health Organization (WHO) Community Periodontal Index (CPI) periodontal probe in all teeth present as described by WHO (2013). The PPD examination is according to the pocket scores provided here: 0 = Absence of condition, 1 = Pocket 4-5mm, 2 = Pocket 6mm or more, 9 = Tooth excluded, X = Tooth not present (The lower the number the healthier the tissue)
  • Periodontal Pocket Depth (PPD) [ Time Frame: 6 months ]
    PPD examination will be performed using a World Health Organization (WHO) Community Periodontal Index (CPI) periodontal probe in all teeth present as described by WHO (2013). The PPD examination is according to the pocket scores provided here: 0 = Absence of condition, 1 = Pocket 4-5mm, 2 = Pocket 6mm or more, 9 = Tooth excluded, X = Tooth not present (The lower the number the healthier the tissue)
  • Periodontal Pocket Depth (PPD) [ Time Frame: 12 months ]
    PPD examination will be performed using a World Health Organization (WHO) Community Periodontal Index (CPI) periodontal

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Colgate Palmolive

    Dates:
    Date Received: January 28, 2016
    Date Started: June 2015
    Date Completion: June 2016
    Last Updated: January 29, 2016
    Last Verified: June 2015