NCT06471881

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 24, 2013

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 24, 2024

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

5.4 years

First QC Date

June 18, 2024

Last Update Submit

August 5, 2024

Conditions

Edentulous Mouth

Keywords

Cohort studyEdentulismImplant overdenturesZirconiaProsthodontic maintenanceDental implants

Outcome Measures

Primary Outcomes (6)

  • Implant Survival

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

    36 months

  • Implant Success

    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

    36 months

  • Prosthetic Survival

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

    36 months

  • Prosthetic Success

    Number of patients with absence of any technical/mechanical complications without the need to repair the dentures (including the attachment systems) or the bars

    36 months

  • Radiological evaluation

    Marginal bone loss

    36 months

  • Radiological examination

    Implant bar fit

    36 months

Study Arms (1)

Zirconia bars with distal extensions

EXPERIMENTAL

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

Device: Two mandibular implants

Interventions

Two mandibular implantsDEVICE

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

Zirconia bars with distal extensions

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bern

Bern, 3010, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 40709726DERIVED

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth Diseases

Study Officials

  • Joannis Katsoulis, Prof.

    University of Bern

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2024

First Posted

June 24, 2024

Study Start

January 24, 2013

Primary Completion

July 1, 2018

Study Completion

July 1, 2024

Last Updated

August 6, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)