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| Sponsor: | National Institute of Dental and Craniofacial Research (NIDCR) |
|---|---|
| Information provided by: | National Institute of Dental and Craniofacial Research (NIDCR) |
| ClinicalTrials.gov Identifier: | NCT00066001 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Periodontitis Periodontal Diseases |
Drug: metronidazole |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study |
| Official Title: | The Effect of Systemically Administered Metronidazole Alone and in Combination With Professional Supragingival Plaque Removal on Plaque Composition |
| Enrollment: | 154 |
| Study Start Date: | December 2002 |
| Estimated Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1, 2, 3, 4: Placebo Comparator
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.
|
Drug: metronidazole
antibiotic that is particularly effective against Gram negative bacterial species
|
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.
Eligibility| Ages Eligible for Study: | 35 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
Contacts and Locations| United States, Massachusetts | |
| Department of Periodontology, The Forsyth Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: | Ann Haffajee | Boston, MA |
More Information
| Responsible Party: | The Forsyth Instititute ( Ann D. Haffajee/PI/Chair Department of Periodontology/Senior Member of the Staff ) |
| Study ID Numbers: | NIDCR-12108 |
| Study First Received: | August 1, 2003 |
| Last Updated: | July 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00066001 History of Changes |
| Health Authority: | United States: Federal Government |
|
Mouth Diseases Anti-Infective Agents Metronidazole Antiparasitic Agents Antiprotozoal Agents Periodontal Diseases |
Radiation-Sensitizing Agents Periodontitis Therapeutic Uses Physiological Effects of Drugs Stomatognathic Diseases Pharmacologic Actions |