drugset / Trial / NCT02839408

Efficacy of Oral Probiotic and Antibiotic Administration in Patients With Chronic Periodontitis

NCT02839408

Phase 2 Unknown 54 enrolled University of Chile
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The aim of this randomized placebo- controlled clinical trial is to evaluate the effects of Lactobacillus rhamnosus SP1- containing probiotic tablets and azithromycin tablets as an adjunct to scaling and root planning (SRP). Material and methods: Fifty-four chronic periodontitis patients will be recruited and monitored clinically, immunologically and microbiologically at baseline, 3, 6, 9 and 12 months after therapy. All patients will receive scaling and root planning and randomly will be assigned over an probiotic experimental (SRP + probiotic, n=18), antibiotic experimental (SRP + Azithromycin, n=18) or control (SRP + placebo, n=18) group. Probiotic will be used once per day during 3 months. Antibiotic will be used once per day during 5 days.

Timeline

Start
2015-06
Primary completion
2016-12
Completion
2017-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Azithromycin Small molecule 500 mg

Indications