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

NCT02839408 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2016-09-27

No results posted yet for this study

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.

Conditions

  • Chronic Periodontitis

Interventions

DIETARY_SUPPLEMENT

Lactobacillus rhamnosus SP1

Sachet containing Lactobacillus rhamnosus SP1

DRUG

Azithromycin

Tablet containing 500mg Azithromicyn

OTHER

Talc powder

Sachet containing talc powder and tablet containing talc powder

PROCEDURE

Periodontal treatment Scaling and root planning

Sponsors & Collaborators

  • University of Chile

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-12-31
Completion
2017-03-31

Countries

  • Chile

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02839408 on ClinicalTrials.gov