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

Phase 2

• Conditions: Chronic Periodontitis
• Interventions: Dietary Supplement: Lactobacillus rhamnosus SP1; Other: Talc powder; Drug: Azithromycin; Procedure: Periodontal treatment Scaling and root planning

• Registration Number: NCT02839408
• Lead Sponsor: University of Chile

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Status Verified: 2016-07
• Study First Submitted: 2016-07-18
• Study First Submitted QC: 2016-07-20
• Study First Posted: 2016-07-21
• Last Update Submitted: 2016-09-25
• Last Update Posted: 2016-09-27
• Primary Completion: 2016-12
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Periodontal treatment, Antibiotic	Periodontal treatment Scaling and root planning	Periodontal treatment (scaling and root planning) and one tablet containing 500mg Azithromycin
Periodontal treatment, Probitic	Lactobacillus rhamnosus SP1	Periodontal treatment (scaling and root planning) and one sachet containing Lactobacillus rhamnosus SP1 per day during 3 months.
Periodontal treatment, Probitic	Periodontal treatment Scaling and root planning	Periodontal treatment (scaling and root planning) and one sachet containing Lactobacillus rhamnosus SP1 per day during 3 months.
Periodontal treatment, talc powder tab	Talc powder	Periodontal treatment (scaling and root planning) and one tablet containing talc powder per day during 3 months
Periodontal treatment, talc powder tab	Periodontal treatment Scaling and root planning	Periodontal treatment (scaling and root planning) and one tablet containing talc powder per day during 3 months
Periodontal treatment, Antibiotic	Azithromycin	Periodontal treatment (scaling and root planning) and one tablet containing 500mg Azithromycin

Primary Outcome Measures

Name	Time	Method
Differences of at least 1mm between groups for clinical attachment level changes	baseline, 3, 6, 9 and 12 month

Secondary Outcome Measures

Name	Time	Method
Differences between groups for probing depth changes	baseline, 3, 6, 9 and 12 month
Differences between groups for bleeding on probing changes	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	baseline, 3, 6, 9 and 12 month
Differences between groups for levels of periodontal pathogens changes	baseline, 3, 6, 9 and 12 month
Differences between groups for plaque index changes	baseline, 3, 6, 9 and 12 month

Trial Locations

Locations (1)

Faculty of Dentistry of University of Chile; 🇨🇱 Santiago, Chile