Clinical and Radiographical Performance of Zirconia Bars for Mandibular Implant Overdentures: A 3-year Follow-up Prospective Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Bern
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Implant Success
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Zirconia bars with distal extensions
Two mandibular implants and a mandibular implant overdenture supported by a computer-aided design
Intervention: Two mandibular implants (Device)
Outcomes
Primary Outcomes
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
Implant Survival
Time Frame: 36 months
Number of patients with continued presence of the implant(s) during the re-examination appointments
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
Prosthetic Survival
Time Frame: 36 months
Number of patients with functional presence of the denture and the bar at the follow-up moments
Radiological evaluation
Time Frame: 36 months
Marginal bone loss
Radiological examination
Time Frame: 36 months
Implant bar fit
Secondary Outcomes
No secondary outcomes reported