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

Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04129684
• Other study ID #: 2019-1015
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: November 30, 2021

Study information

• Verified date: October 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Yanmin Wu, Doctor
• Phone: +86 0571-87783607
• Email: wym731128[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 880
• Est. completion date: November 30, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

Other:
• Probiotics
subgingival delivery and lozenges

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine	Hangzhou	Zhejiang University

Sponsors (4)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Hospital of Stomatology, Jilin University, Peking University Third Hospital, West China College of Stomatology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Change from baseline in Rate of Bleeding on Probing	To evaluate the inflammation and bleeding of gingiva (%)	at baseline, 1, 3 , 6 months
Secondary	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
Secondary	Contents of inflammatory cytokines in periodontal pockets and blood	To observe the effectiveness of the probiotic on systemic and local inflammation: TNF-a; IL-1ß; IL-6; IL-8; IL-10;INF-? (Pg/ml)	at baseline, 1, 3 and 6 months