Clinical trial NCT04129684: A Clinical Trial to Evaluate the Effectiveness of Lactobacillus Reuteri for Periodontitis in a Chinese Population
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontitis
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: West China College of Stomatology
name: Peking University Third Hospital
name: Hospital of Stomatology, Jilin University
First posted: 2019-10-17
Enrollment: 880
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Pocket Probing Depth(PPD)
timeFrame: at 3 months
Secondary outcomes:
measure: Change from baseline in Pocket Probing Depth
timeFrame: at baseline, 1, 6 months
measure: Change from baseline in Clinical Attachment Level
timeFrame: at baseline, 1, 3 , 6 months
measure: Change from baseline in Rate of Bleeding on Probing
timeFrame: at baseline, 1, 3 , 6 months
measure: Number of microorganisms in periodontal pockets
timeFrame: at baseline, 1, 3 and 6 months
measure: Contents of inflammatory cytokines in periodontal pockets and blood
timeFrame: at baseline, 1, 3 and 6 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine
state: Zhejiang University
Study officials:
References: