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

May 9, 2020 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

880

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang University
      • Hangzhou, Zhejiang University, China, 310002
        • Recruiting
        • Second Affiliated Hospital, School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Pocket Probing Depth(PPD)
Time Frame: at 3 months
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
Time Frame: at baseline, 1, 6 months
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
Time Frame: at baseline, 1, 3 , 6 months
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
Time Frame: at baseline, 1, 3 , 6 months
To evaluate the inflammation and bleeding of gingiva (%)
at baseline, 1, 3 , 6 months
Number of microorganisms in periodontal pockets
Time Frame: 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)
at baseline, 1, 3 and 6 months
Contents of inflammatory cytokines in periodontal pockets and blood
Time Frame: 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)
at baseline, 1, 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Peking University Third Hospital
West China College of Stomatology
Hospital of Stomatology, Jilin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

November 30, 2021

Study Registration Dates

First Submitted

October 15, 2019

First Submitted That Met QC Criteria

October 15, 2019

First Posted (Actual)

October 17, 2019

Study Record Updates

Last Update Posted (Actual)

May 12, 2020

Last Update Submitted That Met QC Criteria

May 9, 2020

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-1015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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