Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066001
Status:
COMPLETED
Last Update Posted:
2010-11-09
First Post:
2003-08-01
Brief Title:
Microbial Associations in Periodontal Health and Disease
Sponsor:
The Forsyth Institute
Organization:
The Forsyth Institute
Study Overview
Official Title:
The Effect of Systemically Administered Metronidazole Alone and in Combination With Professional Supragingival Plaque Removal on Plaque Composition
Status:
COMPLETED
Status Verified Date:
2010-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 36 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DE012108 | NIH | None | httpsreporternihgovquickSearchR01DE012108 |