Treating Periodontal Infection: Effects on Glycemic

NCT00016835 | Completed Phase 2 DMC

• 2 other identifiers: NIDCR-035R01DE013796-03
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Disease; Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes mellitus; Glycemic control; Periodontal therapy

Study Arms (3)

Supra-gingival scaling and placebo

ACTIVE COMPARATOR

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

Subgingival scaling and metronidazole

EXPERIMENTAL

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

Subgingival scaling and doxycycline

EXPERIMENTAL

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

Interventions

Supra-gingival scaling and placebo PROCEDURE

Included in arm/group description.

Supra-gingival scaling and placebo

Subgingival scaling and metronidazole PROCEDURE

Included in arm/group description.

Subgingival scaling and metronidazole

Subgingival scaling and doxycycline PROCEDURE

Included in arm/group description.

Subgingival scaling and doxycycline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

Department of Cariology, Restorative Sciences and Endodontics

Ann Arbor, Michigan, 48109-1078, United States

Location

MeSH Terms

Conditions

Periodontal Diseases; Diabetes Mellitus, Type 2

Interventions

Dental Scaling; Metronidazole; Doxycycline

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dental Prophylaxis; Periodontics; Dentistry; Preventive Dentistry; Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• George W. Taylor, DMD, Dr.PH

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants and examiners were unaware of the type of medication and examiners were also unaware of the type of periodontal therapy the participants receive
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Emeritus

Model Details: 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.

Study Record Dates

• First Submitted: June 5, 2001
• First Posted: June 7, 2001
• Study Start: October 17, 2001
• Primary Completion: September 3, 2004
• Study Completion: September 3, 2004
• Last Updated: July 19, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)