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Treating Periodontal Infection: Effects on Glycemic Control in People with Type 2 Diabetes Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Treating Periodontal Infection: Effects on Glycemic Control in People with Type 2 Diabetes conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Treating Periodontal Infection: Effects on Glycemic Control in People with Type 2 Diabetes Clinical research trials and Treating Periodontal Infection: Effects on Glycemic Control in People with Type 2 Diabetes health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Treating Periodontal Infection: Effects on Glycemic Control in People with Type 2 Diabetes. Treating Periodontal Infection: Effects on Glycemic Control in People with Type 2 Diabetes Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Treating Periodontal Infection: Effects on Glycemic Control in People with Type 2 Diabetes clinical trial. Human subjects often get the best healthcare available for their Treating Periodontal Infection: Effects on Glycemic Control in People with Type 2 Diabetes condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Treating Periodontal Infection: Effects on Glycemic Control in People with Type 2 Diabetes  Treating Periodontal Infection: Effects on Glycemic Control in People with Type 2 Diabetes
Treating Periodontal Infection: Effects on Glycemic Control in People with Type 2 Diabetes
For Condition: Diabetes Mellitus, Non-Insulin-Dependent,Periodontal Disease
Status: No longer recruiting
Sponsor(s): National Institute of Dental and Craniofacial Research (NIDCR) ,
Synopsis: 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.
Details: 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 metronidizole) 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 45
Location and Contact Information:
Overall Study Official:
GeorgeTaylor, Principal Investigator, University of Michigan
Department of Cariology, Restorative Sciences and Endodontics
Ann Arbor, Michigan, 48109-1078
United States
Additional Information:
Study ID Numbers: NIDCR-03; R01 DE13796
Study Start Date: April 2001
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016835
Other Diabetes Mellitus, Non-Insulin-Dependent Studies:
1. Evaluate the Role of Adding Amaryl to Non-Insulin Dependent Diabetes Mellitus Patients unresponsive to Maximum Dose Metformin & Thiazolidinedione
2. Disease Management and Educational Intervention Outcomes in High-Risk Diabetics
3. A Research Study to determine the safety and efficacy of Glucovance Compared to Metformin and Glyburide in Children and Adolescents with Type 2 Diabetes.
4. Identification and therapy efficacy of Type 2 diabetes in Hispanic patients
5. Safety and Efficacy of INGAP-Peptide in Patients with Type 2 Diabetes
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Other Diabetes Mellitus, Non-Insulin-Dependent Clinical Trials
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Treating Periodontal Infection: Effects on Glycemic Control in People with Type 2 Diabetes
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