Status:
UNKNOWN
A Clinical Trial to Evaluate the Effectiveness of Lactobacillus Reuteri for Periodontitis in a Chinese Population
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsors:
West China College of Stomatology
Peking University Third Hospital
Conditions:
Periodontitis
Eligibility:
All Genders
18-65 years
Phase:
NA
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 facto...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2021
Estimated Enrollment :
880 Patients enrolled
Trial Details
Trial ID
NCT04129684
Start Date
December 1 2019
End Date
November 30 2021
Last Update
May 12 2020
Active Locations (1)
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1
Second Affiliated Hospital, School of Medicine
Hangzhou, Zhejiang University, China, 310002