Dental Prosthesis FailureNCT05296291
RCT: Titanium vs FCZ vs Zirconia Framework
A study testing High-translucent monolithic zirconia Bridge, Zirconium oxide ceramics Framework and Metal-ceramic Framework in people with Dental Prosthesis Failure, run by Branemarkkliniken at 1 site in Sweden.
Trial summary
In recent years, zirconia-based implant-supported bridge designs have begun to be used more and more as an alternative to metal ceramic bridges. Another new material that has been introduced in the clinic is the high translucent monolithic zirconia, which has only been investigated a few follow-up studies with short… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Dental Prosthesis Failure
- What is being tested?
- High-translucent monolithic zirconia Bridge, Zirconium oxide ceramics Framework and Metal-ceramic Framework
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2020to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- edentulous behind the canine in the maxilla or mandible
- older than 18 years
Who cannot join
- younger than 18 years
- active periodontitis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
B R Å N E M A R K C L I N I C
Gothenburg, 402 33
Jan Kowar
About this study
Official title: RCT Study of Posterior Implant Supported Bridges Made of Various Prosthetic Materials
In recent years, zirconia-based implant-supported bridge designs have begun to be used more and more as an alternative to metal ceramic bridges. Another new material that has been introduced in the clinic is the high translucent monolithic zirconia, which has only been investigated a few follow-up studies with short follow up duration.
The aim being to evaluate the clinical outcome of implant-anchored posterior bridges, made from
Read more
- high-translucent monolithic zirconia,
- zirconia ceramic with porcelain and
- metal ceramics. The hypothesis is that high-translucent monolithic zirconia has lower rate of complications since surface porcelain veneering is not required.
A total of 60 research subjects will be included in the study. Patients in need of a permanent implant-supported bridge, located posterior of the canine in the upper or lower jaw will be asked for participation. Each subject will be treated according to standard treatment protocols with implants from Nobel Biocare, the Branemark implant system and then be randomly assigned to obtain one of the following three type of bridges.
20 research subjects will be included in each of the three study arms. The prosthetic treatment will be carried out according to standard clinic protocol.
All research subjects will be evaluated after 1, 3, 5 years. X-rays and photos will be taken at the installation of the bridges and after 1 and 5 years of follow-up or more frequent, depending on individual indication of the patient and the associated standard clinical care protocol.
Personal data, implant survival, marginal bone loss and biological and technical complications related to the implants will be recorded. Survival of the bridge, technical and biological complication related to the bridge will also be recorded
- Conditions
- Dental Prosthesis Failure
- Being tested
- High-translucent monolithic zirconia Bridge, Zirconium oxide ceramics Framework, Metal-ceramic Framework
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-translucent monolithic zirconia BridgeDevice
Each patient will be treated according to standard of care with implants from Nobel Biocare, the Branmark system and then randomly assigned to receive a bridge made of either 1) metal ceramic (Nobel Procera, titanium skeleton), 2) zirconia ceramics (Nobel Procera zirconia skeleton) or 3) high-translucent monolithic zirconia (Nobel Procera).
Zirconium oxide ceramics FrameworkDevice
Each patient will be treated according to standard of care with implants from Nobel Biocare, the Branmark system and then randomly assigned to receive a bridge made of either 1) metal ceramic (Nobel Procera, titanium skeleton), 2) zirconia ceramics (Nobel Procera zirconia skeleton) or 3) high-translucent monolithic zirconia (Nobel Procera).
Metal-ceramic FrameworkDevice
Each patient will be treated according to standard of care with implants from Nobel Biocare, the Branmark system and then randomly assigned to receive a bridge made of either 1) metal ceramic (Nobel Procera, titanium skeleton), 2) zirconia ceramics (Nobel Procera zirconia skeleton) or 3) high-translucent monolithic zirconia (Nobel Procera).
| Study group | Role | What they receive |
|---|---|---|
| High-translucent monolithic zirconia, | Active comparator | Not described Receives: Device: High-translucent monolithic zirconia Bridge |
| Zirconia ceramic with porcelain | Active comparator | Not described Receives: Device: Zirconium oxide ceramics Framework |
| Metal ceramics. | Active comparator | Not described Receives: Device: Metal-ceramic Framework |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rate
Measured: From placement of prosthetic Bridge until last follow-up of the study after 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start1 Sep 2020
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
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 Dental Prosthesis FailureStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Branemarkkliniken
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296291
- Sponsor's protocol ID
- 2018-1563
- Status last verified
- Mar 2022
- First submitted
- 28 Feb 2022
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kowar J, Turri A, Stenport V, Stervik C, Barkarmo S. Comparison of Materials in Implant-Supported Partial Fixed Dental Prostheses: A Randomized Controlled Trial. Clin Implant Dent Relat Res. 2026 Feb;28(1):e70129. doi: 10.1111/cid.70129.
PubMed 41672962
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT Study of Posterior Implant Supported Bridges Made of Various Prosthetic Materials
- ClinicalTrials.gov ID
- NCT05296291
- Acronym / sponsor ID
- 2018-1563
- Conditions
- Dental Prosthesis Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- BranemarkklinikenUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 25 Mar 2022 (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.
In recent years, zirconia-based implant-supported bridge designs have begun to be used more and more as an alternative to metal ceramic bridges. Another new material that has been introduced in the clinic is the high translucent monolithic zirconia, which has only been investigated a few follow-up studies with short follow up duration.
The aim being to evaluate the clinical outcome of implant-anchored posterior bridges, made from
- high-translucent monolithic zirconia,
- zirconia ceramic with porcelain and
- metal ceramics. The hypothesis is that high-translucent monolithic zirconia has lower rate of complications since surface porcelain veneering is not required.
A total of 60 research subjects will be included in the study. Patients in need of a permanent implant-supported bridge, located posterior of the canine in the upper or lower jaw will be asked for participation. Each subject will be treated according to standard treatment protocols with implants from Nobel Biocare, the Branemark implant system and then be randomly assigned to obtain one of the following three type of bridges.
20 research subjects will be included in each of the three study arms. The prosthetic treatment will be carried out according to standard clinic protocol.
All research subjects will be evaluated after 1, 3, 5 years. X-rays and photos will be taken at the installation of the bridges and after 1 and 5 years of follow-up or more frequent, depending on individual indication of the patient and the associated standard clinical care protocol.
Personal data, implant survival, marginal bone loss and biological and technical complications related to the implants will be recorded. Survival of the bridge, technical and biological complication related to the bridge will also be recorded
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-translucent monolithic zirconia, | Active comparator | Device: High-translucent monolithic zirconia Bridge |
| Zirconia ceramic with porcelain | Active comparator | Device: Zirconium oxide ceramics Framework |
| Metal ceramics. | Active comparator | Device: Metal-ceramic Framework |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- edentulous behind the canine in the maxilla or mandible
- older than 18 years
Key exclusion criteria (2 listed)
- younger than 18 years
- active periodontitis
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 |
|---|---|---|
| High-translucent monolithic zirconia BridgeEach patient will be treated according to standard of care with implants from Nobel Biocare, the Branmark system and then randomly assigned to receive a bridge made of either 1) metal ceramic (Nobel Procera, titanium skeleton), 2) zirconia ceramics (Nobel Procera zirconia skeleton) or 3) high-translucent monolithic zirconia (Nobel Procera). | Device | High-translucent monolithic zirconia, |
| Zirconium oxide ceramics FrameworkEach patient will be treated according to standard of care with implants from Nobel Biocare, the Branmark system and then randomly assigned to receive a bridge made of either 1) metal ceramic (Nobel Procera, titanium skeleton), 2) zirconia ceramics (Nobel Procera zirconia skeleton) or 3) high-translucent monolithic zirconia (Nobel Procera). | Device | Zirconia ceramic with porcelain |
| Metal-ceramic FrameworkEach patient will be treated according to standard of care with implants from Nobel Biocare, the Branmark system and then randomly assigned to receive a bridge made of either 1) metal ceramic (Nobel Procera, titanium skeleton), 2) zirconia ceramics (Nobel Procera zirconia skeleton) or 3) high-translucent monolithic zirconia (Nobel Procera). | Device | Metal ceramics. |
Primary outcome
Complication rate
Time frame: From placement of prosthetic Bridge until last follow-up of the study after 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Derived from this study: PubMed 41672962Kowar J, Turri A, Stenport V, Stervik C, Barkarmo S. Comparison of Materials in Implant-Supported Partial Fixed Dental Prostheses: A Randomized Controlled Trial. Clin Implant Dent Relat Res. 2026 Feb;28(1):e70129. doi: 10.1111/cid.70129.
- Individual participant dataSharing planned: No
Related trials for Dental Prosthesis Failure
Active, not recruiting
Clinical Performance of All-ceramic Posterior Crowns. A Randomized, Prospective Clinical.
Dental Prosthesis Failure
Active, not recruitingObservational study
Survival of Implant-Supported All-Ceramic Prostheses
Partial Edentulism, Disorder of Prostheses and Implants
Active, not recruitingObservational study
Clinical Evaluation of Implants Restored With Advanced Lithium Disilicate Screw-retained Crowns
Dental Prosthesis Failure, Dental Prosthesis Complication
Active, not recruitingObservational study
Clinical Study of a 3D Shaded Zirconia for Chairside CAD/CAM Restorations
Dental Prosthesis Failure, Dental Prosthesis Complication
RecruitingPhase 4
Comparison of Effectiveness of Gingival Displacement Using Retraction Cord and Aluminum Chloride Gel
Gingival Bleeding, Prosthesis Failure, Dental
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-translucent monolithic zirconia Bridge, Zirconium oxide ceramics Framework and Metal-ceramic Framework in people with Dental Prosthesis Failure, run by Branemarkkliniken at 1 site in Sweden.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 25 Mar 2022. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Kowar (+46 700 206817, jan.kowar@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication rate (time frame: From placement of prosthetic Bridge until last follow-up of the study after 5 years). 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 NCT05296291, 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 25 Mar 2022.