Treating Periodontal Infection: Effects on Glycemic Control in People With Type 2 Diabetes
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Periodontal Disease Diabetes Mellitus, Non-Insulin-Dependent |
Procedure: periodontal scaling and local antibiotic irrigation Procedure: systemic antibiotic (either doxycycline or metronidazole). |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Treating Periodontal Infection: Effects on Glycemic Control |
| Estimated Enrollment: | 45 |
| Study Start Date: | April 2001 |
| Estimated Study Completion Date: | October 2008 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
- Subjects must be 18 years of age or older,
- have at least six natural teeth,
- have established periodontal disease (established at the screening examination),
- have a history of type 2 diabetes of at least six months with HbAlc > 7.1%.
Exclusion Criteria
- Subjects will be excluded from the study if they are presently under the care of a periodontist;
- have had antibiotic treatment within the previous three months;
- have conditions that require antibiotic prophylaxis for dental treatment;
- have allergies to iodine, doxycycline, metronidazole, or chlorhexidine;
- have blood dyscrasias;
- are pregnant or breast feeding;
- have severe cognitive or communication impairment;
- have a cardiac pacemaker;
- are under cancer chemotherapy;
- are medically unstable or have a life expectancy of less than two years;
- are currently taking disulfiram, phenobarbital, lithium, terfenadine, astemizole, or warfarin;
- or are out of town or otherwise unavailable for more than three consecutive months of the year.
Contacts and Locations| United States, Michigan | |
| Department of Cariology, Restorative Sciences and Endodontics | |
| Ann Arbor, Michigan, United States, 48109-1078 | |
| Principal Investigator: | George W. Taylor, DMD, Dr.PH | University of Michigan |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00016835 History of Changes |
| Other Study ID Numbers: | NIDCR-03, R01 DE13796 |
| Study First Received: | June 5, 2001 |
| Last Updated: | October 5, 2007 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Dental and Craniofacial Research (NIDCR):
|
Type 2 diabetes mellitus |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Periodontal Diseases Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Mouth Diseases Stomatognathic Diseases Anti-Bacterial Agents Doxycycline |
Metronidazole Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimalarials Antiprotozoal Agents Antiparasitic Agents Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on February 21, 2013
