Efficacy of Oral Probiotic Administration in Patients With Chronic Periodontitis

Phase 2

• Conditions: -Chronic Periodontitis
• Interventions: Other: Talc powder; Other: Lactobacillus rhamnosus SP1; Procedure: Periodontal treatment

• Registration Number: NCT02283736
• Lead Sponsor: Jorge Gamonal

Brief Summary

The aim of this randomized placebo- controlled clinical trial is to evaluate the effects of Lactobacillus rhamnosus SP1- containing probiotic tablets as an adjunct to scaling and root planning (SRP).

Material and methods: Thirty six chronic periodontitis patients will be recruited and monitored clinically, immunologically and microbiologically at baseline, 3 and 6 months after therapy. All patients will receive scaling and root planning and randomly will be assigned over an experimental (SRP + probiotic, n=18) or control (SRP + placebo, n=18) group. The tablets will be used once per day during 3 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-11-01
• Study First Submitted QC: 2014-11-01
• Study First Posted: 2014-11-05
• Primary Completion: 2015-06
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-13
• Last Update Posted: 2016-06-15
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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, 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	Periodontal treatment (scaling and root planning) and one tablet containing talc powder per day during 3 months
Periodontal treatment, Probitic	Lactobacillus rhamnosus SP1	Periodontal treatment (scaling and root planning) and one tablet containing Lactobacillus rhamnosus SP1 per day during 3 months.
Periodontal treatment, Probitic	Periodontal treatment	Periodontal treatment (scaling and root planning) and one tablet containing Lactobacillus rhamnosus SP1 per day during 3 months.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Differences between groups for probing depth changes	baseline, 3, 6 month
Differences between groups for bleeding on probing changes	baseline, 3, 6 months
Differences between groups for plaque index changes	baseline, 3, 6 months
Differences between groups for levels of Interleukin (IL)-17, IL-21, Transforming Growth Factor (TGF)- beta, IL-10, RANKL changes in gingival crevicular fluid	baseline, 3, 6 months
Differences between groups for levels of periodontal pathogens changes	baseline, 3, 6 months

Trial Locations

Locations (1)

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