ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 22 of 87 for:    Recruiting, Not yet recruiting, Available Studies | "Jaw Diseases"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02676661
Recruitment Status : Recruiting
First Posted : February 8, 2016
Last Update Posted : February 8, 2016
Sponsor:
Information provided by (Responsible Party):
Ji-hua Chen, Fourth Military Medical University

Brief Summary:
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.

Condition or disease
Jaw, Edentulous, Partially

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 [Patient Registry]
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: The Prevalence and Risk Factors for Patients With Peri-implant Disease: A Prospective Study
Study Start Date : October 2014
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : December 2022

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. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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
Criteria

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.

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): NCT02676661


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

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

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: NCT02676661     History of Changes
Other Study ID Numbers: Jhchen
First Posted: February 8, 2016    Key Record Dates
Last Update Posted: February 8, 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:
Jaw, Edentulous
Jaw, Edentulous, Partially
Jaw Diseases
Musculoskeletal Diseases
Stomatognathic Diseases
Mouth, Edentulous
Mouth Diseases
Tooth Diseases