Zirconia Bars for Mandibular Implant Overdentures

NCT ID: NCT06471881

Last Updated: 2024-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-24

Study Completion Date

2024-07-01

Brief Summary

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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

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Conditions

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Edentulous Mouth

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Zirconia bars with distal extensions

Two mandibular implants and a mandibular implant overdenture supported by a computer-aided design

Group Type EXPERIMENTAL

Two mandibular implants

Intervention Type DEVICE

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

Interventions

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Two mandibular implants

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joannis Katsoulis, Prof.

Role: STUDY_DIRECTOR

University of Bern

Locations

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University of Bern

Bern, , Switzerland

Site Status

Countries

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Switzerland

References

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Molinero-Mourelle P, Fonseca M, Grossen ME, Zuercher AN, Schimmel M, Katsoulis J. Clinical and Radiographic Evaluation of Zirconia Bars for Mandibular Implant Overdentures: A Prospective Cohort Study With up to 3 Years of Follow-Up. Clin Implant Dent Relat Res. 2025 Aug;27(4):e70066. doi: 10.1111/cid.70066.

Reference Type DERIVED
PMID: 40709726 (View on PubMed)

Other Identifiers

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Zirconia bars

Identifier Type: -

Identifier Source: org_study_id

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