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

Jaw, Edentulous, Partially Clinical Trial

Official title:

The Prevalence and Risk Factors for Patients With Peri-implant Disease：a Retrospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02662361
• Other study ID #: IRB-REV-2014027
• 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

• Jaw, Edentulous
• Jaw, Edentulous, Partially

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