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

Second Affiliated Hospital, Zhejiang University, School of Medicine880 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

880

Conditions

Periodontitis

Interventions

ProbioticsOTHER

subgingival delivery and lozenges

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 18-65 years of age 2. 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 3. Natural teeth remaining in the mouth≥ 14 Exclusion Criteria: 1. Patients with any other systemic diseases which likely to alter the progression and course of periodontitis, except coronary disease, diabetes or hypertension. 2. Patients with aggressive periodontitis. 3. Patients who received any periodontal treatment in the past 6 months 4. Pregnant or lactating women 5. Patients who smoke 6. Patients in the acute phase of an infectious disease 7. Patients taking bisphosphonate mediation 8. Patients who are on any probiotic, anticoagulants or antibiotic supplements for the past 3 months 9. Patients allergic to lactate products 10. Patients who are deemed uncooperative

Locations (1)

Second Affiliated Hospital, School of Medicine

Hangzhou, Zhejiang University, China

RECRUITING

Outcomes

Primary Outcomes

Change From Baseline in Pocket Probing Depth(PPD)

Distance from the base of the periodontal pocket to the gingival margin(mm)

Time frame: at 3 months

Secondary Outcomes

Change from baseline in Pocket Probing Depth

Distance from the base of the periodontal pocket to the gingival margin(mm)

Time frame: 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)

Time frame: at baseline, 1, 3 , 6 months

Change from baseline in Rate of Bleeding on Probing

To evaluate the inflammation and bleeding of gingiva (%)

Time frame: 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)

Time frame: 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)

Time frame: at baseline, 1, 3 and 6 months

Central Contacts

Yanmin Wu, Doctor

CONTACT

+86 0571-87783607 wym731128@126.com

Data from ClinicalTrials.gov

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