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

Not Applicable

• Conditions: Periodontitis
• Interventions: Other: Probiotics

• Registration Number: NCT04129684
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-15
• Study First Submitted QC: 2019-10-15
• Study First Posted: 2019-10-17
• Study Start: 2019-12-01
• Last Update Submitted: 2020-05-09
• Last Update Posted: 2020-05-12
• Primary Completion: 2021-10-01
• Study Completion: 2021-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 880

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Probiotics	SRP+subgingival delivery of placebo and placebo lozenges
Test group	Probiotics	SRP+BioGaia Prodentis oil drops and lozenges

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Pocket Probing Depth(PPD)	at 3 months	Distance from the base of the periodontal pocket to the gingival margin(mm)

Secondary Outcome Measures

Name	Time	Method
Number of microorganisms in periodontal pockets	at baseline, 1, 3 and 6 months	To observe the effectiveness of the probiotic on periodontal microorganisms: P. gingivalis; A. actinomycetemcomitans; T. forsythia; T. denticola; P. intermedia; L. reuteri (CFU)
Change from baseline in Clinical Attachment Level	at baseline, 1, 3 , 6 months	Distance from the base of the periodontal pocket to the CEJ or other fixed reference point (mm)
Change from baseline in Rate of Bleeding on Probing	at baseline, 1, 3 , 6 months	To evaluate the inflammation and bleeding of gingiva (%)
Change from baseline in Pocket Probing Depth	at baseline, 1, 6 months	Distance from the base of the periodontal pocket to the gingival margin(mm)
Contents of inflammatory cytokines in periodontal pockets and blood	at baseline, 1, 3 and 6 months	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)

Trial Locations

Locations (1)

Second Affiliated Hospital, School of Medicine; 🇨🇳 Hangzhou, Zhejiang University, China