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Evaluation of the Prevalence and Risk Factors for Patients With Peri-implant Disease:a Retrospective Study

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ClinicalTrials.gov Identifier: NCT02662361
Recruitment Status : Unknown
Verified January 2016 by Ji-hua Chen, Fourth Military Medical University.
Recruitment status was:  Recruiting
First Posted : January 25, 2016
Last Update Posted : May 6, 2016
Sponsor:
Information provided by (Responsible Party):
Ji-hua Chen, Fourth Military Medical University

Brief Summary:
To investigate the patient-related 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.

Condition or disease
Jaw, Edentulous, Partially

Detailed Description:
Objective: To investigate the patient-related 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. Methods:A total of 131 patients will enroll in the study. Univariate and multivariate logistic regression analysis is used to determine the patient factors associated with peri-implant disease. The variables include age, gender, smoking and alcohol consumption, presence of diabetes, cardiovascular disease, osteoporosis, bruxism, bleeding upon brushing, reason for extraction, oral hygiene and periodontal status.

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Study Type : Observational
Estimated Enrollment : 131 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Prevalence and Risk Factors for Patients With Peri-implant Disease:a Retrospective Study
Study Start Date : October 2014
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

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.



Primary Outcome Measures :
  1. Survival of implants [ Time Frame: at the first return visit(at least one year after restoration) ]
    Time from the surgical placement of implants until the first return visit(at least one year after restoration)


Secondary Outcome Measures :
  1. Gingival Bleeding on Probing [ Time Frame: at the first return visit(at least one year after restoration) ]
    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.

  2. Pocket depths [ Time Frame: at the first return visit(at least one year after restoration) ]
    Pocket depths measured around implants in millimeter (mm)

  3. Marginal bone loss [ Time Frame: at the first return visit(at least one year after restoration) ]
    Time from the surgical placement of implants until the first return visit(at least one year after restoration)



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients restored with implant-supported fixed partial dentures and single crowns at the Department of Prosthodontics, School of Stomatology of the Fourth Military Medical University between January 2011 to May 2014.
Criteria

Inclusion Criteria:

Patients implanted at least one implant and restored with implant-supported fixed partial dentures and single crowns.

The implant-supported fixed partial dentures and single crowns were in function at least one year.

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02662361


Contacts
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Contact: Jihua Chen, PhD 029-84776329 jhchen@fmmu.edu.cn
Contact: Min Tian, PhD 029-84776129 tianminno1@163.com

Locations
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China, Shanxi
Stomatological Hospital of Fourth Military Medical University Recruiting
Xi'an, Shanxi, China, 710032
Contact: Min Tian, PhD    +86 13891862298    tianminno1@163.com   
Contact: Jihua Chen, PhD    +86 13991390388    jhchen@fmmu.edu.cn   
Sub-Investigator: Min Tian, PhD         
Sponsors and Collaborators
Fourth Military Medical University
Investigators
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Principal Investigator: Yongjin Chen, 029-84776488 IRB of Stomatological Hospital of FMMU,PLA

Publications of Results:
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Responsible Party: Ji-hua Chen, Professor and Dean of the Department of Prosthodontics, School of Stomatology, Fourth Military Medical University, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT02662361     History of Changes
Other Study ID Numbers: IRB-REV-2014027
First Posted: January 25, 2016    Key Record Dates
Last Update Posted: May 6, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Ji-hua Chen, Fourth Military Medical University:
peri-implant disease; risk factors; prevalence
Additional relevant MeSH terms:
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Jaw, Edentulous
Jaw, Edentulous, Partially
Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Jaw Diseases
Musculoskeletal Diseases