Edentulous MouthNCT06471881
Zirconia Bars for Mandibular Implant Overdentures
A study testing Two mandibular implants in people with Edentulous Mouth, run by University of Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Edentulous Mouth
- What is being tested?
- Two mandibular implants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 24 Jan 2013to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographical Performance of Zirconia Bars for Mandibular Implant Overdentures: A 3-year Follow-up Prospective Cohort Study
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.
- Conditions
- Edentulous Mouth
- Being tested
- Two mandibular implants
- Keywords
- Cohort study, Edentulism, Implant overdentures, Zirconia, Prosthodontic maintenance, Dental implants
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two mandibular implantsDevice
Rehabilitation with two mandibular implants and a mandibular implant overdenture supported by a computer-aided design bar
| Study group | Role | What they receive |
|---|---|---|
| Zirconia bars with distal extensions | Experimental | Two mandibular implants and a mandibular implant overdenture supported by a computer-aided design Receives: Device: Two mandibular implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Survival
Number of patients with continued presence of the implant(s) during the re-examination appointments
Measured: 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
Measured: 36 months
Prosthetic Survival
Number of patients with functional presence of the denture and the bar at the follow-up moments
Measured: 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
Measured: 36 months
Radiological evaluation
Marginal bone loss
Measured: 36 months
Radiological examination
Implant bar fit
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start24 Jan 2013
- Primary completion1 Jul 2018
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Edentulous MouthStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joannis Katsoulis, Prof., Study director, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471881
- Sponsor's protocol ID
- Zirconia bars
- Status last verified
- Aug 2024
- First submitted
- 18 Jun 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40709726
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographical Performance of Zirconia Bars for Mandibular Implant Overdentures: A 3-year Follow-up Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06471881
- Acronym / sponsor ID
- Zirconia bars
- Conditions
- Edentulous Mouth
- Keywords
- Cohort study, Edentulism, Implant overdentures, Zirconia, Prosthodontic maintenance, Dental implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 24 Jan 2013 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zirconia bars with distal extensions | Experimental | Device: Two mandibular implantsTwo mandibular implants and a mandibular implant overdenture supported by a computer-aided design |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Two mandibular implantsRehabilitation with two mandibular implants and a mandibular implant overdenture supported by a computer-aided design bar | Device | Zirconia bars with distal extensions |
Primary outcome
Implant Survival
Time frame: 36 months
Number of patients with continued presence of the implant(s) during the re-examination appointments
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
Prosthetic Survival
Time frame: 36 months
Number of patients with functional presence of the denture and the bar at the follow-up moments
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
Radiological evaluation
Time frame: 36 months
Marginal bone loss
Radiological examination
Time frame: 36 months
Implant bar fit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Derived from this study: PubMed 40709726Molinero-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joannis Katsoulis, Prof. study director
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two mandibular implants in people with Edentulous Mouth, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Survival (time frame: 36 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06471881, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024; AzTrials last refreshed its copy on 6 Nov 2026.