Periodontal Treatment Response in Type II Diabetic Patients

Status Completed

Clinical Trial Summary

Diabetes mellitus affects > 171 million people worldwide, with type II diabetes being the most prevalent, affecting 85-95% of the diabetic population. Unfortunately, despite conventional medical treatment, some diabetic patients do not seem to be able to reach desirable metabolic control. This is a double-blinded, randomized study investigating the effects of triclosan containing toothpaste (commercial name: Colgate Total) on the response to periodontal treatment in type II diabetic patients with periodontal disease. The investigators believe that using triclosan containing toothpaste during periodontal treatment will decrease the local inflammatory response and that this reduction will improve periodontal status and metabolic control.

Clinical Trial Description

Many studies have shown a relationship between chronic inflammatory periodontal diseases and diabetes, in which both diseases influence the other. Research studies have shown that controlling inflammation of the gums can improve the level of metabolic control (i.e. blood glucose levels) in patients with diabetes. However, it is still not clear which periodontal treatment approach would best maintain the control of inflammation of diabetic patients. Triclosan has anti-plaque and anti-inflammatory properties and decreases gum inflammation. The purpose of this study is to 1) determine the effects of triclosan containing toothpaste on gum inflammation in type II diabetic patients with periodontal disease, and 2) to evaluate whether type II diabetic patients will show improvement in periodontal status and blood glucose following periodontal treatment with and without the use of a triclosan containing toothpaste.

Patients with type II diabetes that meet the study criteria will be randomly assigned either triclosan containing toothpaste or placebo toothpaste. Dental cleanings and oral exams will be performed at baseline, 6 weeks, 3, 6, 9 and 12 months, and samples will be collected at baseline, 3, 6 and 12 months. Samples that may be collected include blood, plaque, gingival crevicular fluid, saliva and plaque. Women may also be asked to complete a pregnancy test. Photographs and x-rays of the patients mouth/teeth may be taken, but is not a requirement.

The samples collected will be used to assess the effect of triclosan containing toothpaste on glycemic control and local and systemic inflammatory mediators during the course of periodontal treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01881074
Study type	Observational
Source	University of Florida
Contact
Status	Completed
Phase
Start date	June 2012
Completion date	December 2015

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.