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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06471881
Enrollment
30
Registered
2024-06-24
Start date
2013-01-24
Completion date
2024-07-01
Last updated
2024-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edentulous Mouth

Keywords

Cohort study, Edentulism, Implant overdentures, Zirconia, Prosthodontic maintenance, Dental implants

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.

Interventions

DEVICETwo mandibular implants

Rehabilitation with two mandibular implants and a mandibular implant overdenture supported by a computer-aided design bar

Sponsors

University of Bern
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
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.

Design outcomes

Primary

MeasureTime frameDescription
Implant Survival36 monthsNumber of patients with continued presence of the implant(s) during the re-examination appointments
Implant Success36 monthsNumber 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 Survival36 monthsNumber of patients with functional presence of the denture and the bar at the follow-up moments
Prosthetic Success36 monthsNumber of patients with absence of any technical/mechanical complications without the need to repair the dentures (including the attachment systems) or the bars
Radiological evaluation36 monthsMarginal bone loss
Radiological examination36 monthsImplant bar fit

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026