Periodontal Disease Clinical Trial
Official title:
The Influence of Periodontal Treatment on Gingival Inflammatory Response of the Type II Diabetic Patient
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.
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.
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