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Periodontal Therapies in Smokers and Non-Smokers
NCT00066066Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2003
- Primary completion
- Jul 2009
- Countries
- 1
- Sponsor
- ADA Forsyth Institute
- Modality
- Small Molecules
- Conditions
- periodontitis
01
Overview
Phase 2, randomised, double-blind trial of metronidazole, amoxicillin and doxycycline in periodontitis (3 arms), sponsored by ADA Forsyth Institute. Primary endpoint: Change in Mean Clinical Attachment Level at 12 months. Started Jul 2003; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Scaling and root planing alone
Full mouth SRP + placebo pill twice daily for 2 weeks.
SRP + Metronidazole
Full mouth SRP + Metronidazole 250 mg tid for 14 days.
SRP + MET + Amoxicillin + Doxycycline
Full mouth SRP + Metronidazole 250 mg tid for 14 days + Amoxicillin 500 mg tid for 14 days + local Doxycycline in pockets >4mm.
03
Who it enrols
Patients with periodontitis (>20 teeth, specific pocket depth/attachment level criteria) who are not pregnant/nursing, have no recent periodontal/antibiotic therapy, and no systemic conditions like diabetes, AIDS, or liver disease.
04
Endpoints
Primary
Change in Mean Clinical Attachment Level
Secondary
Plaque Index
Gingival Index
Percentage of sites with bleeding on probing
Pocket Depth
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