- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02676661
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
Conditions
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
- Name: Jihua Chen, PhD
- Phone Number: 029-84776329
- Email: jhchen@fmmu.edu.cn
Study Contact Backup
- Name: Min Tian, PhD
- Phone Number: 029-84776129
- Email: tianminno1@163.com
Study Locations
-
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Shanxi
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Xi'an, Shanxi, China, 710032
- Recruiting
- Stomatological Hospital of Fourth Military Medical University
-
Contact:
- Min Tian, PhD
- Phone Number: +86 13891862298
- Email: tianminno1@163.com
-
Contact:
- Jihua Chen, PhD
- Phone Number: +86 13991390388
- Email: jhchen@fmmu.edu.cn
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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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Jhchen
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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