Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Treating Periodontal Infection: Effects on Glycemic Control in People With Type 2 Diabetes
The purpose of this project is to obtain important preliminary data necessary to support design of a full scale, multicenter randomized clinical trial (RCT) to evaluate the effect of treating periodontal infection on glycemic control in type 2 diabetes mellitus.
There is compelling epidemiological and clinical evidence to suggest that periodontal
infection adversely affects glycemic control in people with type 2 diabetes mellitus. The
purpose of this pilot project is to obtain important preliminary data necessary to support
design of a full scale, multi-center randomized clinical trial (RCT) to evaluate the effect
of treating periodontal infection on glycemic control in individuals with type 2 diabetes
mellitus. This current project involves treating periodontal infection to obtain estimates of
changes and the variability of those changes over time in the established primary endpoint,
hemoglobin A1c (HbA1c). This project will also explore use of several potential secondary
endpoints including levels of periodontitis and glucose metabolism-related inflammatory
mediators (TNF-alpha, IL-1-beta, IL-6), serum cholesterol, triglyceride and lipids. Subjects
are randomly assigned to 1 of three possible groups for comprehensive periodontal
examination, specimen collection, mechanical periodontal therapy and oral systemic
antibiotics or placebo, and regular follow-up evaluations and site-specific mechanical
periodontal therapy, at 3-month intervals, for approximately 15 months. Two groups receive
ultrasonic scaling with local anesthesia (as needed), local antimicrobial treatment with
povidone-iodine irrigation, and an oral systemic antibiotic (either doxycycline or
metronidazole) at the initial treatment visit. The third group ("controls") receives a
placebo and supra-gingival oral prophylaxis and ultrasonic removal of supra-gingival calculus
with water irrigation at the initial treatment visit. At the 9-month follow-up visit,
"controls" receive sub-gingival ultrasonic scaling with povidone-iodine irrigation.
Results from this pilot project will be used as preliminary data to support design of an
immediate follow-up proposal to NIH/NIDCR for funding a multi-center RCT to evaluate the
effect of treating periodontal infection on glycemic control in type 2 diabetes. If results
from the full scale clinical trial provide evidence that treating periodontal infection
contributes to improved glycemic control, then diagnosis and treatment of periodontal
infection in subjects with type 2 diabetes could be substantiated as an important component
in management of diabetes.
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