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Completed

NCT Number: NCT06471881

Zirconia Bars for Mandibular Implant Overdentures

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.

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Key information

Conditions

Edentulous Mouth Mouth Diseases Mouth, Edentulous Stomatognathic Diseases Tooth Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bern

Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Two mandibular implants

Device

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

Primary outcomes

  1. Implant Survival

    Time frame: 36 months

    Number of patients with continued presence of the implant(s) during the re-examination appointments

  2. 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

  3. Prosthetic Survival

    Time frame: 36 months

    Number of patients with functional presence of the denture and the bar at the follow-up moments

  4. 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

  5. Radiological evaluation

    Time frame: 36 months

    Marginal bone loss

  6. Radiological examination

    Time frame: 36 months

    Implant bar fit

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Registry information

Official study title

Clinical and Radiographical Performance of Zirconia Bars for Mandibular Implant Overdentures: A 3-year Follow-up Prospective Cohort Study

Important dates

Study start
2013
Primary completion
2018
Study completion
2024
First posted
Jun 24, 2024
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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