Prevalence and Risk Indicators of Peri-implant Diseases i... | NCT06208254

Studies
Prevalence and Risk Indicators of Peri-implant Diseases in China

NCT06208254

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Status

Unknown status

Last Update Posted

Jan 17, 2024Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Peri-Implantitis

Interventions

Not provided

Countries

Not provided

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

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 31, 2024Estimated

Primary Completion Date

Jan 31, 2025Estimated

Completion Date

Jan 31, 2025Estimated

First Submitted Date

Jan 3, 2024

First Submission Date that Met QC Criteria

Jan 15, 2024

First Posted Date

Jan 17, 2024Actual

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

Jan 15, 2024

Last Update Posted Date

Jan 17, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityOTHER

Collaborators

Name	Class
Dalian Medical University	OTHER
Nanchang University	OTHER
Ningxia Medical University	OTHER
Shanxi Medical University

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 goal of this multicenter cross-sectional study is to investigate the prevalence of peri-implantitis in China. The main questions it aims to answer are:

What is the prevalence of peri-implantitis in China
What are the risk indicators of peri-implantitis in China

Participants will be invited to a free-of-charge clinical and radiographic examination of conventional dental implants present for over 5 years.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients		Patients having at least one rough surface titanium implant in function for more than 5 years.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bleeding on probing [positive (+) or negative (-)]	When bleeding is present after probing using a periodontal probe with a force of 0.2-0.3 N.	About 5-10 years after surgery
Peri-implant probing depth (mm)	Measured using a periodontal probe inserted into the peri-implant sulcus	About 5-10 years after surgery
Bone loss (mm)	Measured apically from the most coronal portion of the intraosseous part of the implant using periapical radiographs	About 5-10 years after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients having at least one rough surface titanium implant in function for more than 5 years
Patients treated between January 1, 2013 and December 31, 2017
All the implants osseointegrated in the patients' mouth at the time of the examination (including those placed in external clinics) and having at least 5 years of loading, either proven by dental charts or confirmed by the patients, were evaluated

Exclusion Criteria:

Selected patients were invited to participate in the study by telephone calls on the numbers reported in their medical records, and if no response, the patient was not discarded until at least five attempts on different days have been made
Periapical and/or panoramic radiographs unavailable
History of peri-implantitis and/or peri-implant mucositis treatment
Refusal to participate in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients who have conventional dental implants placed and over 5 years of functional loading.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xinbo Yu	Contact	18019409340		xinboyu@proton.me

Overall Officials

Name	Affiliation	Role
Yiqun Wu	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D057873	Peri-Implantitis

Ancestor Terms

ID	Term
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided