NCT02850458

Brief Summary

The purpose of this study is to evaluate the clinical results of implant-retained mandibular overdentures in edentulous patients.

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
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2016

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

February 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

1 year

First QC Date

July 25, 2016

Last Update Submit

February 4, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Survival of implants

    through study completion, an average of 1 year

Secondary Outcomes (3)

  • Gingival Bleeding on Probing

    through study completion, an average of 1 year

  • Pocket depths

    through study completion, an average of 1 year

  • Marginal bone loss

    through study completion, an average of 1 year

Other Outcomes (2)

  • patients' satisfaction

    through study completion, an average of 1 year

  • oral health-related quality of life

    through study completion, an average of 1 year

Study Arms (2)

implant retained-overdentures with the attachment of bar

patients treated with implant-retained overdentures,and the attachment is bar

Device: implant-retained overdentures

implant retained-overdentures with the attachment of magnet

patients treated with implant-retained overdentures,and the attachment is magnet

Device: implant-retained overdentures

Interventions

patients treated with an implant-retained overdenture in the mandible

implant retained-overdentures with the attachment of barimplant retained-overdentures with the attachment of magnet

Eligibility Criteria

Age45 Years - 83 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients treated with implant retained overdentures at the Department of Prosthodontics, School of Stomatology of the Fourth Military Medical University between July 2011 to May 2014.

You may qualify if:

  • Patients treated with implant retained overdentures
  • With the ability to read and sign the informed consent document

You may not qualify if:

  • Jaw radiotherapy treatment before and after implanting
  • Patients who suffered with mental and psychological disease will influence their oral health normal maintenance
  • Can not read and sign the informed consent document

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stomatological Hospital of Fourth Military Medical University

Xi’an, Shanxi, China

RECRUITING

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth Diseases

Study Officials

  • Yong jin chen

    IRB of Stomatological Hospital of FMMU,PLA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ji hua chen, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor and Dean of the Department of Prosthodontics, School of Stomatology, Fourth Military Medical University

Study Record Dates

First Submitted

July 25, 2016

First Posted

August 1, 2016

Study Start

February 1, 2016

Primary Completion

February 1, 2017

Study Completion

August 1, 2017

Last Updated

February 7, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will share

Locations