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Phase 2 N=146 Randomized Quadruple-blind Treatment

Effect of Three Periodontal Therapies in Current Smokers and Non-Smokers

Periodontitis · Periodontal Diseases

Bottom Line

View on ClinicalTrials.gov: NCT00066066 ↗
Enrolled (actual)
146
Serious AEs
6.2%
Results posted
Apr 2013
Primary outcome: Primary: Change in Mean Clinical Attachment Level. — 0.11; 0.10; 0.21; 0.08 mm — p=>0.05

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Scaling and root planing (Procedure); Metronidazole (Drug); Amoxicillin (Drug); Doxycycline (Drug)
Age
Adult, Older Adult · 20+ yrs
Sex
All
Sponsor
The Forsyth Institute
Primary completion
Jul 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Mean Clinical Attachment Level.		 0.11; 0.10; 0.21; 0.08; 0.29; 0.28 >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.

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
View full record on ClinicalTrials.gov →

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.

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