Microbial Associations in Periodontal Health and Disease

Periodontitis Clinical Trial

Official title:

The Effect of Systemically Administered Metronidazole Alone and in Combination With Professional Supragingival Plaque Removal on Plaque Composition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00066001
• Other study ID #: NIDCR-12108
• Secondary ID: R01DE012108
• Status: Completed
• Phase: Phase 2
• First received: August 1, 2003
• Last updated: November 8, 2010
• Start date: December 2002
• Est. completion date: December 2009

Study information

• Verified date: November 2010
• Source: The Forsyth Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: December 2009
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Diseases
• Periodontal Diseases
• Periodontitis

Intervention

Drug:
• metronidazole
antibiotic that is particularly effective against Gram negative bacterial species

Locations

Country	Name	City	State
United States	Department of Periodontology, The Forsyth Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
The Forsyth Institute	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean attachment level		Baseline, 3, 6 12 18 and 24 months	No