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

NCT02676661 | Unknown DMC

• 1 other identifier: Jhchen
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Jaw, Edentulous, Partially

Keywords

peri-implant disease; risk factors; prevalence

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (3)

• Gingival Bleeding on Probing

  at the first day,6 months 1,3 and 5 years after prosthetic loading.

• Pocket depths

  at the first day,6 months 1,3 and 5 years after prosthetic loading.

• Marginal bone loss

  at the first day,6 months 1,3 and 5 years after prosthetic loading.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Partially edentulous patients will implant at least one implant and will be restored with implant-supported fixed partial dentures and single crowns.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Stomatological Hospital of Fourth Military Medical University

Xi’an, Shanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Jaw, Edentulous, Partially

Condition Hierarchy (Ancestors)

Jaw, Edentulous; Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Study Officials

• Yongjin Chen, PhD

  IRB of Stomatological Hospital of FMMU,PLA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jihua Chen, PhD

CONTACT

029-84776329; jhchen@fmmu.edu.cn

Min Tian, PhD

CONTACT

029-84776129; tianminno1@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Dean of the Department of Prosthodontics, School of Stomatology, Fourth Military Medical University

Study Record Dates

• First Submitted: January 24, 2016
• First Posted: February 8, 2016
• Study Start: October 1, 2014
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 8, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)