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

• Conditions: Jaw, Edentulous, Partially

• Registration Number: NCT02676661
• Lead Sponsor: Air Force Military Medical University, China

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.

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 Timeline

• Study Start: 2014-10
• Status Verified: 2016-01
• Study First Submitted: 2016-01-24
• Study First Submitted QC: 2016-02-05
• Last Update Submitted: 2016-02-05
• Study First Posted: 2016-02-08
• Last Update Posted: 2016-02-08
• Primary Completion: 2022-10
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
peri-implant disease	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

Name	Time	Method
Gingival Bleeding on Probing	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.
Pocket depths	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).
Marginal bone loss	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.

Trial Locations

Locations (1)

Stomatological Hospital of Fourth Military Medical University; 🇨🇳 Xi'an, Shanxi, China