Effect of Probiotics as Supplement to Non-surgical Periodontal Treatment

Study Overview
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Brief Summary
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The present study is a double-blinded randomized clinical trial with a duration of 12 weeks.

Detailed Description
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The present study is a double-blinded randomized clinical trial with a duration of 12 weeks . 60 patients with periodontitis stage 2-3, grade B-C, generalized will be allocated in the test (probiotic) and the control (placebo) group at baseline. The intervention is non-surgical periodontal treatment, which will be applied at baseline and followed for 12 weeks. Clinical measurements and sampling will be performed at baseline, week 6 and week 12. Primary endpoint: Changes in microbial composition. Secondary endpoints: Changes in clinical and immunological parameters

Official Title
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Effect of Probiotics as Supplement to Non-surgical Periodontal Treatment

Conditions
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Periodontitis

Intervention / Treatment
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* Dietary Supplement: Probiotic
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Periodontitis stage 2-3, Grade B-C, generalized Exclusion Criteria: • Use of systemic antibiotics within the latest three months.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 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
Interventional Model Description: Double blinded randomized clinical trial with a test and placebo group
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br>In this group participants will receive non-surgical periodontal treatment at baseline, which will for 12 weeks | Dietary Supplement: Probiotic<br>* In this group participants will receive probiotic supplements twice a day (morning and evening) for a period of 12 weeks.<br>|
| Placebo Comparator: Placebo<br>In this group participants will receive non-surgical periodontal treatment at baseline, which will for 12 weeks | Dietary Supplement: Placebo<br>* In this group participants will receive placebo twice a day (morning and evening) for at period of 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in microbial composition in dental plaque | Changes in alpha and beta diversity of microbial composition | Baseline vs. week 6 and week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in dental plaque | Changes in mean level of dental plaque | Baseline vs. week 6 and week 12 | 
| Changes in bleeding on probing | Changes in mean level of bleeding on probing | Baseline vs. week 6 and week 12 | 
| Changes in probing pocket depth | Changes in mean level of probing pocket depth | Baseline vs. week 6 and week 12 | 
| Changes in clinical attachment level | Changes in mean level of clinical attachment level | Baseline vs. week 6 and week 12 | 
| Changes in salivary levels of inflammatory cytokines | Changes in mean salivary levels of selected inflammatory cytokines | Baseline vs. week 6 and week 12 |