drugset / Trial / NCT02197260

Antimicrobial Therapy as Adjunct to Periodontal Treatment: Effect of Timing

NCT02197260 ↗

Phase 4 Completed 80 enrolled University of Geneva, Switzerland
RandomizedCrossoverTriple-blindTreatment

Summary

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.

Timeline

Start
2008-09
Primary completion
2014-03
Completion
2014-03

Outcome

Met primary endpoint

paper At M3, a significantly better primary clinical outcome (persisting pockets of >4 mm with bleeding on probing) PMID 24452825 ↗

paper 3.3 ± 5.1 vs. 6.8 ± 7.8 pockets per patient, p < 0.05 PMID 24452825 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 375 mg —
Subject Metronidazole Small molecule 500 mg —

Indications