A Phase 4 interventional study of 3/d 500 mg metronidazole plus 375 mg amoxicillin for 7 days in Chronic Periodontitis, sponsored by University of Geneva, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 25 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-07-22.
Sponsored by University of Geneva, Switzerland · Phase 4, Interventional, and Treatment
It is common practice to carry out the therapy of periodontal diseases in two phases. In a first, non-surgical phase, bacterial deposits on tooth surfaces (plaque and calculus) are removed using a cleaning method called "scaling and root planing" (SRP). After three to six months the case is evaluated and, if necessary, further treatment is provided, usually taking a more aggressive, surgical approach. Beneficial effects of adjunctive systemic antibiotics on clinical outcomes have been shown repeatedly but specific indications for antibiotics in subgroups of diseased patients, and the optimal timing of antimicrobial therapy, continue to be issues of a long lasting controversy.This study assessed the differential outcomes of periodontal therapy supplemented with amoxicillin-metronidazole during either the non-surgical or the surgical treatment phase.
Single center, randomized placebo controlled crossover clinical trial with a one-year follow-up. Eighty participants with Aggregatibacter actinomycetemcomitans-associated chronic or aggressive periodontitis were randomized into two treatment groups. A: Antibiotics (3/d 500 mg metronidazole plus 375 mg amoxicillin for 7 days) during the first, non-surgical phase of periodontal therapy (T1), and placebo during the second, surgical phase (T2). B: Placebo during T1, and antibiotics during T2. Persistence of sites with a probing depth (PD) >4 mm and bleeding on probing (BOP) was the primary outcome. Evaluations were made three months after T1, as well as 6 and 12 months after T2.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's enrollment of 80 is above the median of 45 across 1,191 interventional studies indexed under Periodontitis.
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Exclusion Criteria:
Antibiotics (3/d 500 mg metronidazole plus 375 mg amoxicillin for 7 days) during the first, non-surgical phase of periodontal therapy (T1), and placebo during the second, surgical phase (T2)
Drug: 3/d 500 mg metronidazole plus 375 mg amoxicillin for 7 days
Placebo during the first, non-surgical phase of periodontal therapy (T1), and antibiotics (3/d 500 mg metronidazole plus 375 mg amoxicillin for 7 days) during the second, surgical phase (T2)
Drug: 3/d 500 mg metronidazole plus 375 mg amoxicillin for 7 days
Systemic antibiotics after sub gingival mechanical debridement
Number of persisting pockets >4 mm bleeding upon probing
Time frame: one year after therapy
Pocket depth of sites with baseline PD >4 mm
Time frame: one year
Adverse events
Time frame: one year
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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University of Geneva, Switzerland