A Clinical Trial to Evaluate the Effectiveness of Lactobacillus Reuteri for Periodontitis in a Chinese Population

Study Overview
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Brief Summary
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The aim of this study is to determine the efficacy of application of Lactobacillus Reuteri probiotics therapy on clinical improvement and on microbial shift in Chinese periodontitis patients.

Detailed Description
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Periodontitis is a chronic inflammatory disease with a prevalence of 80% in Chinese adults, which is the main cause of tooth loss in adults. Periodontitis has also been demonstrated to be a risk factor for cardiovascular diseases, diabetes, and many other systemic diseases due to the host immune response elicited by periodontal pathogenic bacteria. In the last decade, probiotics therapy using Lactobacillus Reuteri has been applied for periodontitis patients in European countries. But no evidence has been provided for its effectiveness in a Chinese population. The aim of this study is to determine the efficacy of application of Lactobacillus Reuteri probiotics therapy on clinical improvement and on microbial shift in Chinese periodontitis patients. The influence of probiotics therapy on the host inflammatory cytokines levels in periodontitis patients with systemic diseases is also evaluated.

Official Title
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A Randomized Single-blind, Parallel-arm Multi-center Clinical Trial to Evaluate the Effectiveness and Safety of Lactobacillus Reuteri for Treatment of Periodontitis in a Chinese Population

Conditions
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Periodontitis

Intervention / Treatment
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* Other: Probiotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 years of age Patients diagnosed with periodontitis clinically evident according to International Classification of Periodontal Diseases (2017) with periodontal probing depth ≥4mm, attachment loss of the most severe site in the adjacent area ≥3mm, and imaging bone loss more than 1/3 of the root length Natural teeth remaining in the mouth≥ 14 Exclusion Criteria: Patients with any other systemic diseases which likely to alter the progression and course of periodontitis, except coronary disease, diabetes or hypertension. Patients with aggressive periodontitis. Patients who received any periodontal treatment in the past 6 months Pregnant or lactating women Patients who smoke Patients in the acute phase of an infectious disease Patients taking bisphosphonate mediation Patients who are on any probiotic, anticoagulants or antibiotic supplements for the past 3 months Patients allergic to lactate products Patients who are deemed uncooperative

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>SRP+BioGaia Prodentis oil drops and lozenges | Other: Probiotics<br>* subgingival delivery and lozenges<br>|
| Placebo Comparator: Control group<br>SRP+subgingival delivery of placebo and placebo lozenges | Other: Probiotics<br>* subgingival delivery and lozenges<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Pocket Probing Depth(PPD) | Distance from the base of the periodontal pocket to the gingival margin(mm) | at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Pocket Probing Depth | Distance from the base of the periodontal pocket to the gingival margin(mm) | at baseline, 1, 6 months | 
| Change from baseline in Clinical Attachment Level | Distance from the base of the periodontal pocket to the CEJ or other fixed reference point (mm) | at baseline, 1, 3 , 6 months | 
| Change from baseline in Rate of Bleeding on Probing | To evaluate the inflammation and bleeding of gingiva (%) | at baseline, 1, 3 , 6 months | 
| Number of microorganisms in periodontal pockets | To observe the effectiveness of the probiotic on periodontal microorganisms: P. gingivalis; A. actinomycetemcomitans; T. forsythia; T. denticola; P. intermedia; L. reuteri (CFU) | at baseline, 1, 3 and 6 months | 
| Contents of inflammatory cytokines in periodontal pockets and blood | To observe the effectiveness of the probiotic on systemic and local inflammation: TNF-α; IL-1β; IL-6; IL-8; IL-10；INF-γ (Pg/ml) | at baseline, 1, 3 and 6 months |