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

Primary Purpose

Periodontitis

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Probiotics

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

Second Affiliated Hospital, School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Test group

Control group

Arm Description

SRP+BioGaia Prodentis oil drops and lozenges

SRP+subgingival delivery of placebo and placebo lozenges

Outcomes

Primary Outcome Measures

Change From Baseline in Pocket Probing Depth(PPD)

Distance from the base of the periodontal pocket to the gingival margin(mm)

Secondary Outcome Measures

Change from baseline in Pocket Probing Depth

Distance from the base of the periodontal pocket to the gingival margin(mm)

Change from baseline in Clinical Attachment Level

Distance from the base of the periodontal pocket to the CEJ or other fixed reference point (mm)

Change from baseline in Rate of Bleeding on Probing

To evaluate the inflammation and bleeding of gingiva (%)

Number of microorganisms in periodontal pockets

To observe the effectiveness of the probiotic on periodontal microorganisms: P. gingivalis; A. actinomycetemcomitans; T. forsythia; T. denticola; P. intermedia; L. reuteri (CFU)

Contents of inflammatory cytokines in periodontal pockets and blood

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)

Full Information

NCT ID

NCT04129684

First Posted

October 15, 2019

Last Updated

May 9, 2020

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04129684

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Unknown status

Study Start Date

December 1, 2019 (Actual)

Primary Completion Date

October 1, 2021 (Anticipated)

Study Completion Date

November 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

880 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Test group

Arm Type

Experimental

Arm Description

SRP+BioGaia Prodentis oil drops and lozenges

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

SRP+subgingival delivery of placebo and placebo lozenges

Intervention Type

Other

Intervention Name(s)

Probiotics

Intervention Description

subgingival delivery and lozenges

Primary Outcome Measure Information:

Title

Change From Baseline in Pocket Probing Depth(PPD)

Description

Distance from the base of the periodontal pocket to the gingival margin(mm)

Time Frame

at 3 months

Secondary Outcome Measure Information:

Title

Change from baseline in Pocket Probing Depth

Description

Distance from the base of the periodontal pocket to the gingival margin(mm)

Time Frame

at baseline, 1, 6 months

Title

Change from baseline in Clinical Attachment Level

Description

Distance from the base of the periodontal pocket to the CEJ or other fixed reference point (mm)

Time Frame

at baseline, 1, 3 , 6 months

Title

Change from baseline in Rate of Bleeding on Probing

Description

To evaluate the inflammation and bleeding of gingiva (%)

Time Frame

at baseline, 1, 3 , 6 months

Title

Number of microorganisms in periodontal pockets

Description

To observe the effectiveness of the probiotic on periodontal microorganisms: P. gingivalis; A. actinomycetemcomitans; T. forsythia; T. denticola; P. intermedia; L. reuteri (CFU)

Time Frame

at baseline, 1, 3 and 6 months

Title

Contents of inflammatory cytokines in periodontal pockets and blood

Description

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)

Time Frame

at baseline, 1, 3 and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yanmin Wu, Doctor

Phone

+86 0571-87783607

wym731128@126.com

Facility Information:

Facility Name

Second Affiliated Hospital, School of Medicine

City

Hangzhou

State/Province

Zhejiang University

ZIP/Postal Code

310002

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yanmin Wu, Doctor

wym731128@126.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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