Evaluation of the Prevalence and Risk Factors for Patients With Peri-implant Disease

February 5, 2016 updated by: Ji-hua Chen, Air Force Military Medical University, China

The Prevalence and Risk Factors for Patients With Peri-implant Disease: A Prospective Study

To investigate the prevalence and risk factors for peri-implant disease in partially edentulous patients rehabilitated with implants supported crown or bridge so as to provide evidence for clinical prevention and control.

Study Overview

Status

Unknown

Detailed Description

The aim of the present study is to identify the prevalence of peri-implant disease in partially edentulous subjects treated with osseointegrated implants, using clinical parameters, as well as to analyse the possible disease association with demographic, behavioural, and biological risk variables.

Study Type

Observational

Enrollment (Anticipated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Shanxi
      • Xi'an, Shanxi, China, 710032
        • Recruiting
        • Stomatological Hospital of Fourth Military Medical University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Min Tian, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Partially edentulous patients implant dental implants and will be restored with implant-supported fixed partial dentures and single crowns at the Department of Prosthodontics, School of Stomatology of the Fourth Military Medical University

Description

Inclusion Criteria:

  • Partially edentulous patients will implant at least one implant and will be restored with implant-supported fixed partial dentures and single crowns.

Exclusion Criteria:

  • Jaw radiotherapy treatment before and after implanting. Patients who have bruxism,xerostomia or the adjacent teeth periapical periodontitis.
  • Patients who suffered with oral mucosa disease,or aggressive periodontitis or jaw defect.
  • Patients who suffered with mental and psychological disease will influence their oral health normal maintenance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
no peri-implant disease
The subjects who did not suffer from peri-implant disease.
peri-implant disease
The subjects who suffered from peri-implant disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
peri-implant disease
Time Frame: at the 5 years after prosthetic loading.
Peri-implant disease includes Peri-implant mucositis and Peri-implantitis.Peri-implant mucositis: BoP/suppuration but no detectable bone loss. Peri-implantitis: BoP/suppuration and bone loss >2 mm.
at the 5 years after prosthetic loading.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival Bleeding on Probing
Time Frame: at the first day,6 months 1,3 and 5 years after prosthetic loading.
Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding.
at the first day,6 months 1,3 and 5 years after prosthetic loading.
Pocket depths
Time Frame: at the first day,6 months 1,3 and 5 years after prosthetic loading.
PD will be measured from the free gingival margin to the base of the pocket and will be recorded in whole millimeters (mm).
at the first day,6 months 1,3 and 5 years after prosthetic loading.
Marginal bone loss
Time Frame: at the first day,6 months 1,3 and 5 years after prosthetic loading.
Marginal bone loss will be assessed by periapical radiographs taken with the paralleling technique.
at the first day,6 months 1,3 and 5 years after prosthetic loading.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Yongjin Chen, PhD, IRB of Stomatological Hospital of FMMU,PLA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

January 24, 2016

First Submitted That Met QC Criteria

February 5, 2016

First Posted (Estimate)

February 8, 2016

Study Record Updates

Last Update Posted (Estimate)

February 8, 2016

Last Update Submitted That Met QC Criteria

February 5, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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