Phase 2
Completed N=146
Effect of Three Periodontal Therapies in Current Smokers and Non-Smokers
Source: ClinicalTrials.gov NCT00066066 ↗Enrolled (actual)
146
Serious AEs
6.2%
Results posted
Apr 2013
Primary outcomePrimary: Change in Mean Clinical Attachment Level. — 0.11; 0.10; 0.21; 0.08 mm — p=>0.05
Summary
The purpose of this study is to determine in current and non-smokers the clinical and microbiological effects of 3 therapies: scaling and root planing (SRP) alone; SRP in combination with the orally administered antibiotic metronidazole; and SRP with the orally administered antibiotics metronidazole and amoxicillin along with the locally delivered antibiotic doxycycline at periodontal pockets >= 4 mm.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Clinical Attachment Level. |
0.11; 0.10; 0.21; 0.08; 0.29; 0.28 | >0.05 |
Eligibility Criteria
Inclusion Criteria
- > 20 teeth
- > 5% sites (approx. 8 sites) with pocket depth > 4 mm and / or 5% sites with attachment level > 4 mm and mean AL 50% of sites with pocket depth or attachment level > 4 mm
- Pregnancy or nursing
- Periodontal or antibiotic therapy in the previous 6 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.)
- Liver disease
- Any known allergy to amoxicillin, metronidazole or doxycycline
- Lactose intolerance
Data sourced from ClinicalTrials.gov (NCT00066066). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.