Microbial Associations in Periodontal Health and Disease

NCT ID: NCT00066001

Last Updated: 2010-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-12-31
• Study Completion Date: 2009-12-31

Brief Summary

The purpose of this study is to determine the clinical and microbiological effects of systemically administered metronidazole alone or in combination with professional plaque removal on periodontally diseased patients.

Detailed Description

Major goals of periodontal research are to differentiate pathogenic from host compatible plaque microbiotas and to optimize treatments to convert the former to the latter. To this end, in the previous award period the composition of supra and subgingival plaques, the associations among species both within and between supra and subgingival plaques, and differences between plaques from healthy and diseased individuals were determined. One major finding was the frequent detection of anaerobic periodontal pathogens at low numbers in supragingival plaque of periodontally diseased and to a lesser extent healthy subjects. Weekly professional supragingival plaque removal for 3 months in 18 periodontitis subjects demonstrated astonishing reductions in the subgingival microbiota which were maintained for 9 months after cessation of the professional program. The composition of the microbiota at 12 months in these subjects was similar to that found in periodontal health. In another of our studies, systemically administered metronidazole produced similar effects. Thus, in SA1 a 2 year randomized clinical trial will be performed comparing the effects of 1) SRP alone or in combination with 2) weekly professional supragingival plaque removal, 3) systemically administered metronidazole or 4) a combination of the 2 on clinical parameters and supra and subgingival plaque composition. 200 periodontitis patients will receive SRP under local anaesthesia and will be randomly assigned to the 4 treatment groups. All subjects will be evaluated clinically and for supra and subgingival plaque composition at 2 weeks, 3, 6, 12, 18 and 24 months. Supra and subgingival plaque samples will be taken separately from the mesial aspect of each tooth and evaluated individually for their content of 40 bacterial species using checkerboard DNA-DNA hybridization providing over 3.6 million bacterial counts. The results will determine if the beneficial effect of the individual therapies persist beyond one year and whether combined treatment produces even greater benefit to the patient.

Conditions

Periodontitis; Periodontal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1, 2, 3, 4

The 4 arms of the study are based on the treatment groups: 1. scaling and root planing alone (SRP); 2. SRP plus repeated professional supragingival plaque removal; 3. SRP + systemically administered metronidazole; 4. SRP + repeated professional supragingival plaque removal + systemically administered metronidazole.

Group Type: PLACEBO_COMPARATOR

metronidazole

Intervention Type: DRUG

antibiotic that is particularly effective against Gram negative bacterial species

Interventions

metronidazole

antibiotic that is particularly effective against Gram negative bacterial species

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• > 35 years of age
• > 20 teeth
• > 5% sites (approx. 8 sites) with pocket depth > 4 mm and / or 5% sites with attachment level > 4 mm

Exclusion:

• > 50% of sites with pocket depth or attachment level > 4 mm
• Pregnancy or lactation
• Periodontal or antibiotic therapy in the previous 12 months
• Any systemic condition which might influence the course of periodontal disease or treatment (e.g. diabetes, AIDS)
• Any systemic condition which requires antibiotic coverage for routine periodontal procedures (e.g. heart conditions, joint replacements etc.)
• Any known allergy to metronidazole

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role: collaborator

The Forsyth Institute

OTHER

Sponsor Role: lead

Responsible Party

The Forsyth Instititute

Principal Investigators

Ann Haffajee

Role: PRINCIPAL_INVESTIGATOR

Boston, MA

Locations

Department of Periodontology, The Forsyth Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

R01DE012108

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIDCR-12108

Identifier Type: -

Identifier Source: org_study_id