Zirconia Bars for Mandibular Implant Overdentures

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: Edentulous Mouth
• Intervention / Treatment: Device: Two mandibular implants

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	Number of patients with continued presence of the implant(s) during the re-examination appointments	36 months
Implant Success	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	Number of patients with functional presence of the denture and the bar at the follow-up moments	36 months
Prosthetic Success	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	Marginal bone loss	36 months
Radiological examination	Implant bar fit	36 months

Collaborators and Investigators

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

Study record dates

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: Cohort study; Dental implants; Zirconia; Edentulism; Implant overdentures; Prosthodontic maintenance
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• 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