Efficacy of Oral Probiotic Administration in Patients With Chronic Periodontitis

Study Overview
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Brief Summary
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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.

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

Conditions
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-Chronic Periodontitis

Intervention / Treatment
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* Other: Lactobacillus rhamnosus SP1
* Other: Talc powder
* Procedure: Periodontal treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Periodontal treatment, Probitic<br>Periodontal treatment (scaling and root planning) and one tablet containing Lactobacillus rhamnosus SP1 per day during 3 months. | Other: Lactobacillus rhamnosus SP1<br>* Tablet containing Lactobacillus rhamnosus SP1<br>Procedure: Periodontal treatment<br>* Scaling and root planning<br>|
| Placebo Comparator: Periodontal treatment, talc powder tab<br>Periodontal treatment (scaling and root planning) and one tablet containing talc powder per day during 3 months | Other: Talc powder<br>* Tablet containing talc powder<br>Procedure: Periodontal treatment<br>* Scaling and root planning<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences of at least 1mm between groups for clinical attachment level changes |  | baseline, 3, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic periodontitis, Probiotics, Non- surgical treatment