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

  • STATUS
    Recruiting
  • End date
    Nov 30, 2021
  • participants needed
    880
  • sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
Updated on 24 January 2021
periodontal disease
periodontal probing

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.

Details
Condition Periodontitis
Treatment probiotics
Clinical Study IdentifierNCT04129684
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 65 yrs?
Gender: Male or Female
Do you have Periodontitis?
Do you have any of these conditions: Do you have Periodontitis??
18-65 years of age
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
Natural teeth remaining in the mouth 14

Exclusion Criteria

Patients with any other systemic diseases which likely to alter the progression and course of periodontitis, except coronary disease, diabetes or hypertension
Patients with aggressive periodontitis
Patients who received any periodontal treatment in the past 6 months
Pregnant or lactating women
Patients who smoke
Patients in the acute phase of an infectious disease
Patients taking bisphosphonate mediation
Patients who are on any probiotic, anticoagulants or antibiotic supplements for the past 3 months
Patients allergic to lactate products
Patients who are deemed uncooperative
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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