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Treating Periodontal Infection: Effects on Glycemic

This study has been completed.
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
George W. Taylor, University of Michigan
ClinicalTrials.gov Identifier:
NCT00016835
First received: June 5, 2001
Last updated: July 14, 2017
Last verified: July 2017
  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, Type 2 Procedure: Supra-gingival scaling and placebo Procedure: Subgingival scaling and metronidazole Procedure: Subgingival scaling and doxycycline Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Study participants were randomized into 3 groups for the initial non-surgical treatment appointment. One group received supra-gingival scaling and placebo, one group received non-surgical periodontal supra- and sub-gingival scaling plus metronidazole and one group received non-surgical periodontal supra- and sub-gingival scaling plus doxycycline. All three groups received 3-month follow-up visits for 15 months and the group receiving supra-gingival scaling and placebo at the initial visit received supra- and sub-gingival scaling at the 9-month follow-up visit.
Masking: Double (Participant, Care Provider)
Masking Description:
Participants and examiners were unaware of the type of medication and examiners were also unaware of the type of periodontal therapy the participants receive
Primary Purpose: Treatment
Official Title: Treating Periodontal Infection: Effects on Glycemic Control in People With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by George W. Taylor, University of Michigan:

Enrollment: 46
Actual Study Start Date: October 17, 2001
Study Completion Date: September 3, 2004
Primary Completion Date: September 3, 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Supra-gingival scaling and placebo

This group receives a placebo (instead of systemic antibiotic), 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, this group will receive sub-gingival ultrasonic scaling with povidone-iodine irrigation.

This group also receives regular follow-up evaluations and site-specific mechanical periodontal therapy, at 3-month intervals, for approximately 15 months.

Procedure: Supra-gingival scaling and placebo
Included in arm/group description.
Experimental: Subgingival scaling and metronidazole

This group receives ultrasonic scaling with local anesthesia (as needed), local antimicrobial treatment with povidone-iodine irrigation, and metronidazole as an oral systemic antibiotic at the initial treatment visit.

This group also receives regular follow-up evaluations and site-specific mechanical periodontal therapy, at 3-month intervals, for approximately 15 months.

Procedure: Subgingival scaling and metronidazole
Included in arm/group description.
Experimental: Subgingival scaling and doxycycline

This group receives ultrasonic scaling with local anesthesia (as needed), local antimicrobial treatment with povidone-iodine irrigation, and doxycycline as an oral systemic antibiotic at the initial treatment visit.

This group also receives regular follow-up evaluations and site-specific mechanical periodontal therapy, at 3-month intervals, for approximately 15 months.

Procedure: Subgingival scaling and doxycycline
Included in arm/group description.

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
University of Michigan
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Principal Investigator: George W. Taylor, DMD, Dr.PH University of Michigan
  More Information

Responsible Party: George W. Taylor, Professor Emeritus, University of Michigan
ClinicalTrials.gov Identifier: NCT00016835     History of Changes
Other Study ID Numbers: NIDCR-03
5R01DE013796-03 ( U.S. NIH Grant/Contract )
Study First Received: June 5, 2001
Last Updated: July 14, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no current plan to share data with other researchers at this time

Keywords provided by George W. Taylor, University of Michigan:
Type 2 diabetes mellitus
Glycemic control
Periodontal therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Periodontal Diseases
Gingival Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Mouth Diseases
Stomatognathic Diseases
Metronidazole
Doxycycline
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Bacterial Agents
Antimalarials

ClinicalTrials.gov processed this record on September 21, 2017