Efficacy of Oral Probiotic and Antibiotic 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 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.

Official Title
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Efficacy of Oral Probiotic and Antibiotic 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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* Dietary Supplement: Lactobacillus rhamnosus SP1
* Drug: Azithromycin
* Other: Talc powder
* Procedure: Periodontal treatment Scaling and root planning


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 |
| --- | --- |
| 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>* Sachet containing talc powder and tablet containing talc powder<br>Procedure: Periodontal treatment Scaling and root planning<br> <br> |
| Experimental: Periodontal treatment, Probitic<br>Periodontal treatment (scaling and root planning) and one sachet containing Lactobacillus rhamnosus SP1 per day during 3 months. | Dietary Supplement: Lactobacillus rhamnosus SP1<br>* Sachet containing Lactobacillus rhamnosus SP1<br>Procedure: Periodontal treatment Scaling and root planning<br> <br> |
| Experimental: Periodontal treatment, Antibiotic<br>Periodontal treatment (scaling and root planning) and one tablet containing 500mg Azithromycin | Drug: Azithromycin<br>* Tablet containing 500mg Azithromicyn<br>Procedure: Periodontal treatment Scaling and root planning<br> <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, 9 and 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 plaque index 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periodontitis, azithromycin, probiotic