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Trial record 1 of 195 for:    "National Institute of Dental and Craniofacial Research (NIDCR)" [Exact]
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Treating Periodontal Infection: Effects on Glycemic Control in People With Type 2 Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by National Institute of Dental and Craniofacial Research (NIDCR).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Dental and Craniofacial Research (NIDCR)
ClinicalTrials.gov Identifier:
NCT00016835
First received: June 5, 2001
Last updated: October 5, 2007
Last verified: October 2007
  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

Resource links provided by NLM:


Further study details as provided by National Institute of Dental and Craniofacial Research (NIDCR):

Estimated Enrollment: 45
Study Start Date: April 2001
Estimated Study Completion Date: October 2008
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00016835

Locations
United States, Michigan
Department of Cariology, Restorative Sciences and Endodontics
Ann Arbor, Michigan, United States, 48109-1078
Sponsors and Collaborators
Investigators
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
Periodontitis
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Metronidazole
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Antitubercular Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014