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

Zhejiang University

Status: Unknown

Conditions: Periodontitis

Treatments: Other: Probiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT04129684

2019-1015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 880 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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880 participants in 2 patient groups, including a placebo group

Test group

Experimental group

Description:

SRP+BioGaia Prodentis oil drops and lozenges

Treatment:

Other: Probiotics

Control group

Placebo Comparator group

Description:

SRP+subgingival delivery of placebo and placebo lozenges

Treatment:

Other: Probiotics