Implant-supported Single CrownsMonoZrO2crownNCT02272491
Monolithic Zirconia Crowns for Single Implants in the Molar Region: a Multicenter Clinical Trial
A study testing ZrO2 (Straumann CARES) and PFM crown (Straumann Gold) in people with Implant-supported Single Crowns, run by University of Zurich at 1 site in Switzerland.
Trial summary
The aim of the present study is to test whether or not the use of translucent monolithic zirconia crowns bonded to a titanium base abutment perform similar to porcelain-fused-to-metal crowns on single implants in the posterior region. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Implant-supported Single Crowns
- What is being tested?
- ZrO2 (Straumann CARES) and PFM crown (Straumann Gold)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2014to 1 Nov 2027
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent as documented by signature
- Male and female patients from 18-80 years of age
- Presence of a Straumann Tissue Level implant with a regular platform (4.8 mm diameter platform) in the maxillary or mandibular molar region
- Need for a single implant-supported crown
- Implant position enabling screw-retained crown
- Presence of antagonist
Who cannot join
- Women who are pregnant at the date of inclusion
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Smoking more than 15 cigarettes a day
- Poor oral hygiene (Plaque Index over 30%)
- Bruxism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monolithic Zirconia Crowns for Single Implants in the Molar Region: a Randomized Controlled Clinical Trial
The aim of the present study is to test whether or not the use of translucent monolithic zirconia crowns bonded to a titanium base abutment perform similar to porcelain-fused-to-metal crowns on single implants in the posterior region.
Read the detailed description
In the majority of studies on implant-supported restorations, a considerable rate of fractures of the veneering ceramic was reported. The clinical data is restricted to full-ceramic implant-supported reconstructions in the anterior region. No clinical data is available on the performance of full-ceramic restorations in the molar region.
The use of translucent monolithic zirconia for implant-supported crowns (without veneering ceramic) may reduce the technical complication rate and allow for sufficient aesthetic results in the molar region. To date, no clinical trial investigating monolithic zirconia crowns for single molar implants is available.
The primary outcome of the study is the technical complication rate. This outcome represents an indicator for the prosthetic success of the implant-supported crown. The main biological secondary outcomes are marginal bone level, histological signs of inflammation, and presence of pathogenic bacteria. Further outcomes are crown survival, wear of the crown and of the antagonist.
- Conditions
- Implant-supported Single Crowns
- Being tested
- ZrO2 (Straumann CARES), PFM crown (Straumann Gold)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZrO2 (Straumann CARES)Device
- Straumann CARES Variobase Abutment RN
- Straumann CARES Full Contour Zerion HT The monolithic zircona crown (2) will be bonded to the titanium base (1)
PFM crown (Straumann Gold)Device
Porcelain-fused-to-metal crown consisting of a gold abutment, a gold core, and veneering ceramic
| Study group | Role | What they receive |
|---|---|---|
| ZrO2 | Experimental | 1. Straumann CARES Variobase Abutment RN
2. Straumann CARES Full Contour Zerion HT The monolithic zircona crown (2) will be bonded to the titanium base (1) Receives: Device: ZrO2 (Straumann CARES) |
| PFM crown | Active comparator | Straumann Gold Abutment RN Porcelain-fused-to-metal crown consisting of a gold abutment, a gold core, and veneering ceramic Receives: Device: PFM crown (Straumann Gold) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical complication rate
assessed by USPHS-criteria
Measured: 5 years
Secondary outcomes (4)
Survival rate
Measured: 6-month, 1, 3, 5, 7, 10 years
Biological complication rate
assessed by bleeding on probing, pocket probing depth, marginal bone level
Measured: 6-month, 1, 3, 5, 7, 10 years
Wear rate of the antagonist
assessed by a volumetric analysis software
Measured: 6-month, 1, 3, 5, 7, 10 years
Technical complication rate
assessed by USPHS-criteria
Measured: 6-month, 1, 3 , 7, 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study startOct 2014
- Primary completion25 Nov 2022
- Study completion1 Nov 2027 (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 Implant-supported Single CrownsStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- ITI Foundation
- Responsible party
- Sponsor
- Investigators
- Alexis Ioannidis, Dr., Principal investigator, Clinic of Reconstructive Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272491
- Sponsor's protocol ID
- 2014-0191
- Acronym
- MonoZrO2crown
- Status last verified
- May 2023
- First submitted
- 10 Oct 2014
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhang Y, Muhlemann S, Pachiou A, Stalder SA, Jung RE, Lin Y, Thoma DS. Peri-Implant Soft Tissue Response to Monolithic Zirconia Versus Porcelain-Fused-to-Metal Implant Crowns: Histological and Clinical Outcomes of an RCT. J Clin Periodontol. 2026 Jul 15. doi: 10.1111/jcpe.70169. Online ahead of print.
PubMed 42457202
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monolithic Zirconia Crowns for Single Implants in the Molar Region: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02272491
- Acronym / sponsor ID
- MonoZrO2crown / 2014-0191
- Conditions
- Implant-supported Single Crowns
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- ITI Foundation
- Study start
- Oct 2014 (actual)
- Primary completion
- 25 Nov 2022 (actual)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 23 Oct 2014 (estimated)
- 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.
The aim of the present study is to test whether or not the use of translucent monolithic zirconia crowns bonded to a titanium base abutment perform similar to porcelain-fused-to-metal crowns on single implants in the posterior region.
Detailed description
In the majority of studies on implant-supported restorations, a considerable rate of fractures of the veneering ceramic was reported. The clinical data is restricted to full-ceramic implant-supported reconstructions in the anterior region. No clinical data is available on the performance of full-ceramic restorations in the molar region.
The use of translucent monolithic zirconia for implant-supported crowns (without veneering ceramic) may reduce the technical complication rate and allow for sufficient aesthetic results in the molar region. To date, no clinical trial investigating monolithic zirconia crowns for single molar implants is available.
The primary outcome of the study is the technical complication rate. This outcome represents an indicator for the prosthetic success of the implant-supported crown. The main biological secondary outcomes are marginal bone level, histological signs of inflammation, and presence of pathogenic bacteria. Further outcomes are crown survival, wear of the crown and of the antagonist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZrO2 | Experimental | Device: ZrO2 (Straumann CARES)1. Straumann CARES Variobase Abutment RN 2. Straumann CARES Full Contour Zerion HT The monolithic zircona crown (2) will be bonded to the titanium base (1) |
| PFM crown | Active comparator | Device: PFM crown (Straumann Gold)Straumann Gold Abutment RN Porcelain-fused-to-metal crown consisting of a gold abutment, a gold core, and veneering ceramic |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed Consent as documented by signature
- Male and female patients from 18-80 years of age
- Presence of a Straumann Tissue Level implant with a regular platform (4.8 mm diameter platform) in the maxillary or mandibular molar region
- Need for a single implant-supported crown
- Implant position enabling screw-retained crown
Key exclusion criteria (6 listed)
- Women who are pregnant at the date of inclusion
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Smoking more than 15 cigarettes a day
- Poor oral hygiene (Plaque Index over 30%)
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 |
|---|---|---|
| ZrO2 (Straumann CARES)1. Straumann CARES Variobase Abutment RN 2. Straumann CARES Full Contour Zerion HT The monolithic zircona crown (2) will be bonded to the titanium base (1) | Device | ZrO2 |
| PFM crown (Straumann Gold)Porcelain-fused-to-metal crown consisting of a gold abutment, a gold core, and veneering ceramic | Device | PFM crown |
Primary outcome
Technical complication rate
Time frame: 5 years
assessed by USPHS-criteria
4 secondary outcomes
Survival rate
Time frame: 6-month, 1, 3, 5, 7, 10 years
Biological complication rate
Time frame: 6-month, 1, 3, 5, 7, 10 years
Wear rate of the antagonist
Time frame: 6-month, 1, 3, 5, 7, 10 years
Technical complication rate
Time frame: 6-month, 1, 3 , 7, 10 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 15 May 2023.
- Derived from this study: PubMed 42457202Zhang Y, Muhlemann S, Pachiou A, Stalder SA, Jung RE, Lin Y, Thoma DS. Peri-Implant Soft Tissue Response to Monolithic Zirconia Versus Porcelain-Fused-to-Metal Implant Crowns: Histological and Clinical Outcomes of an RCT. J Clin Periodontol. 2026 Jul 15. doi: 10.1111/jcpe.70169. Online ahead of print.
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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.
Alexis Ioannidis, Dr. principal investigator
Clinic of Reconstructive Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ZrO2 (Straumann CARES) and PFM crown (Straumann Gold) in people with Implant-supported Single Crowns, run by University of Zurich 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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 15 May 2023. 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?
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?
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?
Technical complication rate (time frame: 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 NCT02272491, 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 15 May 2023.