Zirconia Bars for Mandibular Implant Overdentures
- Conditions
- Edentulous Mouth
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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
- Primary Outcome Measures
Name Time Method 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
Radiological examination 36 months Implant bar fit
Implant Survival 36 months Number of patients with continued presence of the implant(s) during the re-examination appointments
Prosthetic Survival 36 months Number of patients with functional presence of the denture and the bar at the follow-up moments
Radiological evaluation 36 months Marginal bone loss
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Bern
🇨🇭Bern, Switzerland
University of Bern🇨🇭Bern, Switzerland