Clinical Results of Implant-retained Mandibular Overdentures in Edentulous Patients

February 4, 2017 updated by: Ji-hua Chen

Clinical Results of Implant-retained Mandibular Overdentures in Edentulous Patients: A 5-year Retrospective Study

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The survival of implants,condition of the peri-implant soft tissue were evaluated. And patients' perceptions regarding the outcome were assessed on visual analog scales (VAS), oral health impact profile-14 (OHIP) and semantic differential scale questionnaires.

Study Type

Observational

Enrollment (Anticipated)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanxi
      • Xi'an, Shanxi, China
        • Recruiting
        • Stomatological Hospital of Fourth Military Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
implant retained-overdentures with the attachment of bar
patients treated with implant-retained overdentures,and the attachment is bar
Device: implant-retained overdentures
patients treated with an implant-retained overdenture in the mandible
implant retained-overdentures with the attachment of magnet
patients treated with implant-retained overdentures,and the attachment is magnet
Device: implant-retained overdentures
patients treated with an implant-retained overdenture in the mandible

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival of implants
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival Bleeding on Probing
Time Frame: through study completion, an average of 1 year
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
through study completion, an average of 1 year
Pocket depths
Time Frame: through study completion, an average of 1 year
Pocket depths measured around implants in millimeter (mm)
through study completion, an average of 1 year
Marginal bone loss
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
patients' satisfaction
Time Frame: through study completion, an average of 1 year
patients' satisfaction were assessed on visual analog scales (VAS)
through study completion, an average of 1 year
oral health-related quality of life
Time Frame: through study completion, an average of 1 year
Patients completed a 14-item Oral Health Impact Profile (OHIP-14) to assess oral health-related quality of life
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ji-hua Chen

Investigators

  • Principal Investigator: Yong jin chen, IRB of Stomatological Hospital of FMMU,PLA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

July 25, 2016

First Submitted That Met QC Criteria

July 29, 2016

First Posted (Estimate)

August 1, 2016

Study Record Updates

Last Update Posted (Estimate)

February 7, 2017

Last Update Submitted That Met QC Criteria

February 4, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-REV-2016036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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