Overview

This trial is active, not recruiting.

Condition chronic periodontitis
Treatments lactobacillus rhamnosus sp1, azithromycin, talc powder, periodontal treatment scaling and root planning
Phase phase 2
Sponsor University of Chile
Start date June 2015
End date December 2016
Trial size 54 participants
Trial identifier NCT02839408, FONDECYT 1130570.b

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Periodontal treatment (scaling and root planning) and one tablet containing talc powder per day during 3 months
talc powder
Sachet containing talc powder and tablet containing talc powder
periodontal treatment scaling and root planning
(Experimental)
Periodontal treatment (scaling and root planning) and one sachet containing Lactobacillus rhamnosus SP1 per day during 3 months.
lactobacillus rhamnosus sp1
Sachet containing Lactobacillus rhamnosus SP1
periodontal treatment scaling and root planning
(Experimental)
Periodontal treatment (scaling and root planning) and one tablet containing 500mg Azithromycin
azithromycin
Tablet containing 500mg Azithromicyn
periodontal treatment scaling and root planning

Primary Outcomes

Measure
Differences of at least 1mm between groups for clinical attachment level changes
time frame: baseline, 3, 6, 9 and 12 month

Secondary Outcomes

Measure
Differences between groups for probing depth changes
time frame: baseline, 3, 6, 9 and 12 month
Differences between groups for bleeding on probing changes
time frame: baseline, 3, 6, 9 and 12 month
Differences between groups for plaque index changes
time frame: baseline, 3, 6, 9 and 12 month
Differences between groups for levels of Interleukin (IL)-17, IL-8, beta-defensing 3 changes in gingival crevicular fluid
time frame: baseline, 3, 6, 9 and 12 month
Differences between groups for levels of periodontal pathogens changes
time frame: baseline, 3, 6, 9 and 12 month

Eligibility Criteria

Male or female participants at least 35 years old.

Inclusion Criteria: - 14 natural teeth, excluding third molars - 10 posterior teeth - 35 years old - 5 teeth with periodontal sites with probing depths ≥5mm, clinical attachment loss ≥3mm Bleeding on probing ≥20% of sites Extensive bone loss determined radiographically Exclusion Criteria: - Periodontal treatment before the time of examination - Systemic illness - Pregnancy Anticoagulant, antibiotics and non- steroid anti- inflammatory therapy in the 6-month period before the study

Additional Information

Official title Efficacy of Oral Probiotic and Antibiotic Administration in Clinical, Immunological and Microbiological Parameters of Patients With Chronic Periodontitis Treated With Non Surgical Periodontal Treatment
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Chile.