Zirconia Bars for Mandibular Implant Overdentures

August 5, 2024 updated by: University of Bern

Clinical and Radiographical Performance of Zirconia Bars for Mandibular Implant Overdentures: A 3-year Follow-up Prospective Cohort Study

Purpose: To assess the clinical and radiographic outcomes of computer-aided designed and manufactured (CAD-CAM) zirconia bars supporting mandibular implant-retained overdentures (IODs) after a 3-year follow-up.

Methods: A prospective observational single-center study involving 30 edentulous patients rehabilitated with two mandibular implants and a mandibular implant overdenture supported by a computer-aided design - computer-assisted manufacturing zirconia bar with distal extensions was performed assessing clinical and radiographic parameters.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • University of Bern

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Edentulous individuals for more than one year.
  • Individuals with sufficient anatomical bone conditions in the interforaminal area to place implants of 4.3mm in diameter and at least 10.0mm in length without bone augmentation needs.
  • Written consent to participate and to attend the study and the yearly follow-ups.

Exclusion Criteria:

  • Individuals suffered from psychiatric problems.
  • History of cerebrovascular or cardiovascular accident within the last six months.
  • Uncontrolled or insulin-dependent diabetes, immuno-compromised status, current chemotherapy, and leukocyte system diseases.
  • Severe systemic health conditions do not allow surgical intervention with local anesthesia.
  • Irradiated bone.
  • Severe parafunctional habits
  • Drugs or alcohol abuse.
  • Insufficient oral hygiene.
  • Unrealistic treatment demands.
  • Smokers were not excluded, but a cessation protocol was suggested before the implant treatment.
  • Unwillingness to participate in the study.

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zirconia bars with distal extensions
Two mandibular implants and a mandibular implant overdenture supported by a computer-aided design
Device: Two mandibular implants
Rehabilitation with two mandibular implants and a mandibular implant overdenture supported by a computer-aided design bar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Survival
Time Frame: 36 months
Number of patients with continued presence of the implant(s) during the re-examination appointments
36 months
Implant Success
Time Frame: 36 months
Number of patients with absence of persisting subjective discomfort such as pain, foreign body perception and or dysesthesia (i.e., painful sensation), absence of a recurrent peri-implant infection with suppuration, absence of implant mobility on manual palpation, absence of any continuous peri-implant radiolucency
36 months
Prosthetic Survival
Time Frame: 36 months
Number of patients with functional presence of the denture and the bar at the follow-up moments
36 months
Prosthetic Success
Time Frame: 36 months
Number of patients with absence of any technical/mechanical complications without the need to repair the dentures (including the attachment systems) or the bars
36 months
Radiological evaluation
Time Frame: 36 months
Marginal bone loss
36 months
Radiological examination
Time Frame: 36 months
Implant bar fit
36 months

Collaborators and Investigators

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

Sponsor

University of Bern

Investigators

  • Study Director: Joannis Katsoulis, Prof., University of Bern

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 (Actual)

January 24, 2013

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2024

Study Registration Dates

First Submitted

June 18, 2024

First Submitted That Met QC Criteria

June 18, 2024

First Posted (Actual)

June 24, 2024

Study Record Updates

Last Update Posted (Actual)

August 6, 2024

Last Update Submitted That Met QC Criteria

August 5, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Zirconia bars

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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