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Microbial Associations in Periodontal Health and Disease

Primary Purpose

Periodontitis, Periodontal Diseases

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
metronidazole
Sponsored by
The Forsyth Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion: > 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

Sites / Locations

  • Department of Periodontology, The Forsyth Institute

Arms of the Study

Arm 1

Arm Type

Placebo Comparator

Arm Label

1, 2, 3, 4

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in mean attachment level

Secondary Outcome Measures

Full Information

First Posted
August 1, 2003
Last Updated
November 8, 2010
Sponsor
The Forsyth Institute
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
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1. Study Identification

Unique Protocol Identification Number
NCT00066001
Brief Title
Microbial Associations in Periodontal Health and Disease
Official Title
The Effect of Systemically Administered Metronidazole Alone and in Combination With Professional Supragingival Plaque Removal on Plaque Composition
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The Forsyth Institute
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Periodontal Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1, 2, 3, 4
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
metronidazole
Intervention Description
antibiotic that is particularly effective against Gram negative bacterial species
Primary Outcome Measure Information:
Title
Change in mean attachment level
Time Frame
Baseline, 3, 6 12 18 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion: > 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Haffajee
Organizational Affiliation
Boston, MA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Periodontology, The Forsyth Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Microbial Associations in Periodontal Health and Disease

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