NCT02839408

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

Efficacy of Oral Probiotic and Antibiotic Administration in Clinical, Immunological and Microbiological Parameters of Patients With Chronic Periodontitis Treated With Non Surgical Periodontal Treatment

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: University of Chile · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-12-01
• Completion: 2017-03-01
• First posted: 2016-07-21
• Last updated: 2016-09-27

Locations

1 site across 1 country: Chile