Zirconia Bars for Mandibular Implant Overdentures

Not Applicable

Completed

• Conditions: Edentulous Mouth
• Interventions: Device: Two mandibular implants

• Registration Number: NCT06471881
• Lead Sponsor: University of Bern

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-24
• Primary Completion: 2018-07-01
• Study First Submitted: 2024-06-18
• Study First Submitted QC: 2024-06-18
• Study First Posted: 2024-06-24
• Study Completion: 2024-07-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Zirconia bars with distal extensions	Two mandibular implants	Two mandibular implants and a mandibular implant overdenture supported by a computer-aided design

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Bern; 🇨🇭 Bern, Switzerland