A Clinical Trial to Evaluate the Effectiveness of Lactoba... | NCT04129684

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

NCT04129684

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Unknown status

Last Update Posted

May 12, 2020Actual

Enrollment

880Estimated

Phase

Not Applicable

Conditions

Periodontitis

Interventions

Probiotics

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2019Actual

Primary Completion Date

Oct 1, 2021Estimated

Completion Date

Nov 30, 2021Estimated

First Submitted Date

Oct 15, 2019

First Submission Date that Met QC Criteria

Oct 15, 2019

First Posted Date

Oct 17, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2020

Last Update Posted Date

May 12, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang UniversityOTHER

Collaborators

Name	Class
West China College of Stomatology	OTHER
Peking University Third Hospital	OTHER
Hospital of Stomatology, Jilin University	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

880Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test group	Experimental	SRP+BioGaia Prodentis oil drops and lozenges	Other: Probiotics
Control group	Placebo Comparator	SRP+subgingival delivery of placebo and placebo lozenges	Other: Probiotics

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Probiotics	Other	subgingival delivery and lozenges	Control group Test group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Change from baseline in Pocket Probing Depth	Distance from the base of the periodontal pocket to the gingival margin(mm)	at baseline, 1, 6 months
Change from baseline in Clinical Attachment Level

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yanmin Wu, Doctor	Contact	+86 0571-87783607		wym731128@126.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Second Affiliated Hospital, School of Medicine	Recruiting	Hangzhou	Zhejiang University	310002	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010518	Periodontitis

Ancestor Terms

ID	Term
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019936	Probiotics

Ancestor Terms

ID	Term
D019587	Dietary Supplements
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided