NCT02662361

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
131

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 25, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 6, 2016

Status Verified

January 1, 2016

Enrollment Period

1.7 years

First QC Date

January 20, 2016

Last Update Submit

May 5, 2016

Conditions

Keywords

peri-implant disease; risk factors; prevalence

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (3)

  • Gingival Bleeding on Probing

    at the first return visit(at least one year after restoration)

  • Pocket depths

    at the first return visit(at least one year after restoration)

  • Marginal bone loss

    at the first return visit(at least one year after restoration)

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

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients restored with implant-supported fixed partial dentures and single crowns at the Department of Prosthodontics, School of Stomatology of the Fourth Military Medical University between January 2011 to May 2014.

You may qualify if:

  • 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.

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stomatological Hospital of Fourth Military Medical University

Xi’an, Shanxi, 710032, China

RECRUITING

Related 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. doi: 10.1111/j.1600-051X.2006.01001.x.

MeSH Terms

Conditions

Jaw, Edentulous, Partially

Condition Hierarchy (Ancestors)

Jaw, EdentulousJaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Study Officials

  • Yongjin Chen, 029-84776488

    IRB of Stomatological Hospital of FMMU,PLA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jihua Chen, PhD

CONTACT

Min Tian, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
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 20, 2016

First Posted

January 25, 2016

Study Start

October 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

May 6, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will share

Locations