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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02662361
Other study ID # IRB-REV-2014027
Secondary ID
Status Recruiting
Phase N/A
First received January 20, 2016
Last updated May 5, 2016
Start date October 2014
Est. completion date June 2016

Study information

Verified date January 2016
Source Fourth Military Medical University
Contact Jihua Chen, PhD
Phone 029-84776329
Email jhchen@fmmu.edu.cn
Is FDA regulated No
Health authority China: Ethics Committee
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 131
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 85 Years
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
China Stomatological Hospital of Fourth Military Medical University Xi'an Shanxi

Sponsors (1)

Lead Sponsor Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

Ferreira SD, Silva GL, Cortelli JR, Costa JE, Costa FO. Prevalence and risk variables for peri-implant disease in Brazilian subjects. J Clin Periodontol. 2006 Dec;33(12):929-35. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Survival of implants Time from the surgical placement of implants until the first return visit(at least one year after restoration) at the first return visit(at least one year after restoration) No
Secondary Gingival Bleeding on Probing 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 return visit(at least one year after restoration) No
Secondary Pocket depths Pocket depths measured around implants in millimeter (mm) at the first return visit(at least one year after restoration) No
Secondary Marginal bone loss Time from the surgical placement of implants until the first return visit(at least one year after restoration) at the first return visit(at least one year after restoration) No
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