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

Jaw, Edentulous, Partially Clinical Trial

Official title:

The Prevalence and Risk Factors for Patients With Peri-implant Disease： A Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02676661
• Other study ID #: Jhchen
• Status: Recruiting
• Phase: N/A
• First received: January 24, 2016
• Last updated: February 5, 2016
• Start date: October 2014
• Est. completion date: December 2022

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 [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: December 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	peri-implant disease	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.	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 day,6 months 1,3 and 5 years after prosthetic loading.	No
Secondary	Pocket depths	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.	No
Secondary	Marginal bone loss	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.	No