Microbial Associations in Periodontal Health and Disease

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
The Forsyth Institute
ClinicalTrials.gov Identifier:
NCT00066001
First received: August 1, 2003
Last updated: November 8, 2010
Last verified: November 2010

August 1, 2003
November 8, 2010
December 2002
December 2007   (final data collection date for primary outcome measure)
Change in mean attachment level [ Time Frame: Baseline, 3, 6 12 18 and 24 months ] [ Designated as safety issue: No ]
  • Periodontal attachment level
  • Periodontal pocket depth
  • Counts of 40 subgingival bacterial species
Complete list of historical versions of study NCT00066001 on ClinicalTrials.gov Archive Site
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Microbial Associations in Periodontal Health and Disease
The Effect of Systemically Administered Metronidazole Alone and in Combination With Professional Supragingival Plaque Removal on Plaque Composition

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Periodontitis
  • Periodontal Diseases
Drug: metronidazole
antibiotic that is particularly effective against Gram negative bacterial species
Placebo Comparator: 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.
Intervention: Drug: metronidazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
154
December 2009
December 2007   (final data collection date for primary outcome measure)

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
Both
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00066001
NIDCR-12108, R01DE012108
No
Ann D. Haffajee/PI/Chair Department of Periodontology/Senior Member of the Staff, The Forsyth Instititute
The Forsyth Institute
National Institute of Dental and Craniofacial Research (NIDCR)
Principal Investigator: Ann Haffajee Boston, MA
The Forsyth Institute
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP