A Clinical Trial to Evaluate the Effectiveness of Lactobacillus Reuteri for Periodontitis in a Chinese Population
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
1 other identifier
interventional
880
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2019
CompletedFirst Posted
Study publicly available on registry
October 17, 2019
CompletedStudy Start
First participant enrolled
December 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2021
CompletedMay 12, 2020
October 1, 2019
1.8 years
October 15, 2019
May 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Change from baseline in Pocket Probing Depth
at baseline, 1, 6 months
Change from baseline in Clinical Attachment Level
at baseline, 1, 3 , 6 months
Change from baseline in Rate of Bleeding on Probing
at baseline, 1, 3 , 6 months
Number of microorganisms in periodontal pockets
at baseline, 1, 3 and 6 months
Contents of inflammatory cytokines in periodontal pockets and blood
at baseline, 1, 3 and 6 months
Study Arms (2)
Test group
EXPERIMENTALSRP+BioGaia Prodentis oil drops and lozenges
Control group
PLACEBO COMPARATORSRP+subgingival delivery of placebo and placebo lozenges
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Second Affiliated Hospital, School of Medicine
Hangzhou, Zhejiang University, 310002, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2019
First Posted
October 17, 2019
Study Start
December 1, 2019
Primary Completion
October 1, 2021
Study Completion
November 30, 2021
Last Updated
May 12, 2020
Record last verified: 2019-10