Treating Periodontal Infection: Effects on Glycemic

NCT ID: NCT00016835

Last Updated: 2017-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-17
• Study Completion Date: 2004-09-03

Brief 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.

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.

Conditions

Periodontal Disease; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Supra-gingival scaling and placebo

Intervention Type: PROCEDURE

Included in arm/group description.

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.

Group Type: EXPERIMENTAL

Subgingival scaling and metronidazole

Intervention Type: PROCEDURE

Included in arm/group description.

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.

Group Type: EXPERIMENTAL

Subgingival scaling and doxycycline

Intervention Type: PROCEDURE

Included in arm/group description.

Interventions

Supra-gingival scaling and placebo

Included in arm/group description.

Intervention Type: PROCEDURE

Subgingival scaling and metronidazole

Included in arm/group description.

Intervention Type: PROCEDURE

Subgingival scaling and doxycycline

Included in arm/group description.

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

George W. Taylor

Professor Emeritus

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

George W. Taylor, DMD, Dr.PH

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

Department of Cariology, Restorative Sciences and Endodontics

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

5R01DE013796-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIDCR-03

Identifier Type: -

Identifier Source: org_study_id