Treating Periodontal Infection: Effects on Glycemic Control in People With Type 2 Diabetes
Summary
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.
Description
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.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Conditions
Periodontal Disease
Intervention
periodontal scaling and local antibiotic irrigation, systemic antibiotic (either doxycycline or metronidazole).
Location
Department of Cariology, Restorative Sciences and Endodontics
Ann Arbor
Michigan
United States
48109-1078
Status
Active, not recruiting
Source
National Institute of Dental and Craniofacial Research (NIDCR)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00016835
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:56:54-0400
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Medical and Biotech [MESH] Definitions
Porfiromycin
Toxic antibiotic of the mitomycin group, obtained from MITOMYCIN and also from Streptomyces ardus and other species. It is proposed as an antineoplastic agent, with some antibiotic properties.
Periodontal Debridement
Removal or disruption of DENTAL DEPOSITS and plaque-retentive DENTAL CALCULUS from tooth surfaces and within the periodontal pocket space without deliberate removal of CEMENTUM as done in ROOT PLANING and often in DENTAL SCALING. The goal is to conserve dental cementum to help maintain or re-establish healthy periodontal environment and eliminate PERIODONTITIS by using light instrumentation strokes and nonsurgical techniques (e.g., ultrasonic, laser instruments).
Mupirocin
A topically used antibiotic from a strain of Pseudomonas fluorescens. It has shown excellent activity against gram-positive staphylococci and streptococci. The antibiotic is used primarily for the treatment of primary and secondary skin disorders, nasal infections, and wound healing.
Chloramphenicol
An antibiotic first isolated from cultures of Streptomyces venequelae in 1947 but now produced synthetically. It has a relatively simple structure and was the first broad-spectrum antibiotic to be discovered. It acts by interfering with bacterial protein synthesis and is mainly bacteriostatic. (From Martindale, The Extra Pharmacopoeia, 29th ed, p106)
Tobramycin
An aminoglycoside, broad-spectrum antibiotic produced by Streptomyces tenebrarius. It is effective against gram-negative bacteria, especially the PSEUDOMONAS species. It is a 10% component of the antibiotic complex, NEBRAMYCIN, produced by the same species.
