Posterior Single Edentulous SitesNCT06865209
Monolithic Zirconia Posterior Single Crowns: a Randomized Clinical Trial.
A study testing Monolithic Zirconia Posterior Single Screw Retained Implant Crowns in people with Posterior Single Edentulous Sites, run by University of Barcelona at 1 site in Spain.
Trial summary
Monolithic Zirconia Posterior Single Crown cost-efficiency study. Objective and subjective analysis will be performed through FIPS and PROMs scales to evaluate treatment quality outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Posterior Single Edentulous Sites
- What is being tested?
- Monolithic Zirconia Posterior Single Screw Retained Implant Crowns
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 19 Feb 2021to 9 Jan 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Restorable implants
- No signs or previous history of periimplantitis
- Natural antagonist teeth
- Natural adjacent teeth
Who cannot join
- Non restorable implants
- Signs or previous history of periimplantitis
- No natural antagonist teeth
- No natural adjacent teeth
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Odontolico de Bellvitge Universidad de Barcelona
Barcelona, Barcelona, 08907
About this study
Official title: Monolithic Zirconia Posterior Single Crowns. a Time-Efficiency Study of a Complete Digital Flow: a Randomized Clinical Trial.
Monolithic Zirconia Posterior Single Crown cost-efficiency study. Objective and subjective analysis will be performed through FIPS and PROMs scales to evaluate treatment quality outcomes.
Read the detailed description
Introduction Posterior implant single crowns have become the treatment of choice for single tooth replacement in the posterior sectors, due to its biological implications and minimally invasive approach since it requires no preparation of the adjacent tooth and enabling a more efficient hygiene for the patient than a bridge restoration. However, implant-based restorations require more time and economical resources from the patient and the dentist compared to traditional teeth-supported restorations.
Currently the main interest is set upon broadening the potential patient spectrum for this kind of therapies, which can only be achieved by significally reducing the clinical treatment time and technical production time while maintaining an acceptable profit ratio and good quality treatment outcome.
Objectives The main goal of this study is to determine whether monolithic screw retained posterior implant crowns (test) are more time-efficient than metal ceramic screw retained posterior implant. Moreover, as secondary objectives every screw retained crown will be submitted for Functional Implant Prosthodontic Score (FIPS) and Patient Related Outcome Measures (PROMs) evaluation. Hypothesis Monolithic screw-retained posterior single implant crowns performed through a full digital workflow are more time-efficient than conventional-digital workflow fabricated metal-porcelain screw-retained posterior single implant crowns.
Monolitihic single posterior screw-retained implant crowns achieve better quality outcomes than metal porcelain single posterior screw-retained implant crowns.
Material \& Methods A total of 40 implants placed at Master de Integrada de Adultos will participate in a time- efficiency study that will compare monolithic screw-retained posterior implant crowns to metal ceramic screw-retained posterior implant crowns ( gold standard), moreover, every restoration will be submitted for Functional Implant Prosthetic Score (FIPS) and Patient Related Outcome Measures (PROMs)
- Conditions
- Posterior Single Edentulous Sites
- Being tested
- Monolithic Zirconia Posterior Single Screw Retained Implant Crowns
- Keywords
- Single Posterior Implant Crowns, Cost Efficiency, Monolithic Zirconia Crowns, Full Digital Workflow, 3D Printed Prototype
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monolithic Zirconia Posterior Single Screw Retained Implant CrownsDevice
Posterior single edentulous sites will be rehabilitated with monolithic zirconia single posterior implant crowns following two different full digital workflows
| Study group | Role | What they receive |
|---|---|---|
| Direct Finish Single Posterior Monolithic Zirconia Screw Retained Implant Crowns | Experimental | Direct finish single posterior monolithic zirconia screw retained implant crowns, performed with full digital flow direct finish prosthetic protocol. Receives: Device: Monolithic Zirconia Posterior Single Screw Retained Implant Crowns |
| 3d Prototype Guided Single Posterior Monolithic Zirconia Screw Retained Implant Crowns | Active comparator | Direct finish single posterior monolithic zirconia screw retained implant crowns, performed with full digital flow direct finish prosthetic protocol. Receives: Device: Monolithic Zirconia Posterior Single Screw Retained Implant Crowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost
Analyze how many cost units (monetary unit) are needed to make monolithic zirconia single posterior implant supported crowns to assess economic profitability of theses crowns
Measured: From the first visit to definitive crown placement
Efficiency
Analyze how much time are needed to make monolithic zirconia single posterior implant supported crowns to assess economic profitability of theses crowns
Measured: From the first visit to definitive crown placement
Secondary outcomes (3)
Functional Implant Prosthetic Score (FIPS)
Analyze treatment quality outcomes according to the Functional Implant Prosthetic Score. Score 0-10
Measured: 1 week post-op to 1 year follow up
Patient Related Outcome Measures (PROMs)
Analyze how the patient perceives treatment outcomes according to the Patient Related Outcome Measures scale. Score 0-10
Measured: 1 week post-op to 1 year follow up
Accuracy
Analyze castless full digital workflow accuracy, comparing the matching accuracy of the definitive crowns to the digital wax up for both groups. Both STL meshes will be analyzed with Shape Designer by 3 Shape to asses how does the physical prostheses match the virtual wax ups
Measured: Prosthetic Baseline to Definitive Crown Placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start19 Feb 2021
- Primary completion9 Jun 2024
- Study completion9 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Posterior Single Edentulous SitesStudies 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
- Model description
- Cost-efficiency study parallel study following CONSORT requisites
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo Galván Lobo, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865209
- Sponsor's protocol ID
- 33/2020
- Status last verified
- Feb 2025
- First submitted
- 24 Jan 2021
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brånemark PI, Zarb G, Albrektsson T, editors. Chicago: : Quintessence Publishing; 1985. Tissue-integrated prostheses: Osseointegration in clinical dentistry
Mayer TM, Hawley CE, Gunsolley JC, Feldman S. The single-tooth implant: a viable alternative for single-tooth replacement. J Periodontol. 2002 Jul;73(7):687-93. doi: 10.1902/jop.2002.73.7.687.
PubMed 12146526Levin L, Sadet P, Grossmann Y. A retrospective evaluation of 1,387 single-tooth implants: a 6-year follow-up. J Periodontol. 2006 Dec;77(12):2080-3. doi: 10.1902/jop.2006.060220.
PubMed 17209794Muftu A, Chapman RJ. Replacing posterior teeth with freestanding implants: four-year prosthodontic results of a prospective study. J Am Dent Assoc. 1998 Aug;129(8):1097-102. doi: 10.14219/jada.archive.1998.0384.
PubMed 9715010Schwartz-Arad D, Samet N, Samet N. Single tooth replacement of missing molars: a retrospective study of 78 implants. J Periodontol. 1999 Apr;70(4):449-54. doi: 10.1902/jop.1999.70.4.449.
PubMed 10328659Jung SW, Lee JK, Um HS, Chang BS. A retrospective study on survival rate of the most posterior single tooth implant. J Korean Acad Periodontol. 2008;38:611-620.
Salvi GE, Bragger U. Mechanical and technical risks in implant therapy. Int J Oral Maxillofac Implants. 2009;24 Suppl:69-85.
PubMed 19885435De Boever AL, Keersmaekers K, Vanmaele G, Kerschbaum T, Theuniers G, De Boever JA. Prosthetic complications in fixed endosseous implant-borne reconstructions after an observations period of at least 40 months. J Oral Rehabil. 2006 Nov;33(11):833-9. doi: 10.1111/j.1365-2842.2006.01638.x.
PubMed 17002743Vigolo P, Givani A, Majzoub Z, Cordioli G. Cemented versus screw-retained implant-supported single-tooth crowns: a 4-year prospective clinical study. Int J Oral Maxillofac Implants. 2004 Mar-Apr;19(2):260-5.
PubMed 15101598Nedir R, Bischof M, Szmukler-Moncler S, Belser UC, Samson J. Prosthetic complications with dental implants: from an up-to-8-year experience in private practice. Int J Oral Maxillofac Implants. 2006 Nov-Dec;21(6):919-28.
PubMed 17190302Bragger U, Aeschlimann S, Burgin W, Hammerle CH, Lang NP. Biological and technical complications and failures with fixed partial dentures (FPD) on implants and teeth after four to five years of function. Clin Oral Implants Res. 2001 Feb;12(1):26-34. doi: 10.1034/j.1600-0501.2001.012001026.x.
PubMed 11168268Sethi A, Kaus T, Sochor P, Axmann-Krcmar D, Chanavaz M. Evolution of the concept of angulated abutments in implant dentistry: 14-year clinical data. Implant Dent. 2002;11(1):41-51. doi: 10.1097/00008505-200201000-00013.
PubMed 11915544Koutouzis T, Wennstrom JL. Bone level changes at axial- and non-axial-positioned implants supporting fixed partial dentures. A 5-year retrospective longitudinal study. Clin Oral Implants Res. 2007 Oct;18(5):585-90. doi: 10.1111/j.1600-0501.2007.01386.x. Epub 2007 Jun 30.
PubMed 17608740Tawil G, Aboujaoude N, Younan R. Influence of prosthetic parameters on the survival and complication rates of short implants. Int J Oral Maxillofac Implants. 2006 Mar-Apr;21(2):275-82.
PubMed 16634499Rokni S, Todescan R, Watson P, Pharoah M, Adegbembo AO, Deporter D. An assessment of crown-to-root ratios with short sintered porous-surfaced implants supporting prostheses in partially edentulous patients. Int J Oral Maxillofac Implants. 2005 Jan-Feb;20(1):69-76.
PubMed 15747676
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monolithic Zirconia Posterior Single Crowns. a Time-Efficiency Study of a Complete Digital Flow: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06865209
- Acronym / sponsor ID
- 33/2020
- Conditions
- Posterior Single Edentulous Sites
- Keywords
- Single Posterior Implant Crowns, Cost Efficiency, Monolithic Zirconia Crowns, Full Digital Workflow, 3D Printed Prototype
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Study start
- 19 Feb 2021 (actual)
- Primary completion
- 9 Jun 2024 (actual)
- Study completion
- 9 Jan 2026 (estimated)
- First posted
- 7 Mar 2025 (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.
Monolithic Zirconia Posterior Single Crown cost-efficiency study. Objective and subjective analysis will be performed through FIPS and PROMs scales to evaluate treatment quality outcomes.
Detailed description
Introduction Posterior implant single crowns have become the treatment of choice for single tooth replacement in the posterior sectors, due to its biological implications and minimally invasive approach since it requires no preparation of the adjacent tooth and enabling a more efficient hygiene for the patient than a bridge restoration. However, implant-based restorations require more time and economical resources from the patient and the dentist compared to traditional teeth-supported restorations.
Currently the main interest is set upon broadening the potential patient spectrum for this kind of therapies, which can only be achieved by significally reducing the clinical treatment time and technical production time while maintaining an acceptable profit ratio and good quality treatment outcome.
Objectives The main goal of this study is to determine whether monolithic screw retained posterior implant crowns (test) are more time-efficient than metal ceramic screw retained posterior implant. Moreover, as secondary objectives every screw retained crown will be submitted for Functional Implant Prosthodontic Score (FIPS) and Patient Related Outcome Measures (PROMs) evaluation. Hypothesis Monolithic screw-retained posterior single implant crowns performed through a full digital workflow are more time-efficient than conventional-digital workflow fabricated metal-porcelain screw-retained posterior single implant crowns.
Monolitihic single posterior screw-retained implant crowns achieve better quality outcomes than metal porcelain single posterior screw-retained implant crowns.
Material \& Methods A total of 40 implants placed at Master de Integrada de Adultos will participate in a time- efficiency study that will compare monolithic screw-retained posterior implant crowns to metal ceramic screw-retained posterior implant crowns ( gold standard), moreover, every restoration will be submitted for Functional Implant Prosthetic Score (FIPS) and Patient Related Outcome Measures (PROMs)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Cost-efficiency study parallel study following CONSORT requisites
| Arm | Type | Receives |
|---|---|---|
| Direct Finish Single Posterior Monolithic Zirconia Screw Retained Implant Crowns | Experimental | Device: Monolithic Zirconia Posterior Single Screw Retained Implant CrownsDirect finish single posterior monolithic zirconia screw retained implant crowns, performed with full digital flow direct finish prosthetic protocol. |
| 3d Prototype Guided Single Posterior Monolithic Zirconia Screw Retained Implant Crowns | Active comparator | Device: Monolithic Zirconia Posterior Single Screw Retained Implant CrownsDirect finish single posterior monolithic zirconia screw retained implant crowns, performed with full digital flow direct finish prosthetic protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Restorable implants
- No signs or previous history of periimplantitis
- Natural antagonist teeth
- Natural adjacent teeth
Key exclusion criteria (4 listed)
- Non restorable implants
- Signs or previous history of periimplantitis
- No natural antagonist teeth
- No natural adjacent teeth
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 |
|---|---|---|
| Monolithic Zirconia Posterior Single Screw Retained Implant CrownsPosterior single edentulous sites will be rehabilitated with monolithic zirconia single posterior implant crowns following two different full digital workflows | Device | 3d Prototype Guided Single Posterior Monolithic Zirconia Screw Retained Implant Crowns, Direct Finish Single Posterior Monolithic Zirconia Screw Retained Implant Crowns |
Primary outcome
Cost
Time frame: From the first visit to definitive crown placement
Analyze how many cost units (monetary unit) are needed to make monolithic zirconia single posterior implant supported crowns to assess economic profitability of theses crowns
Efficiency
Time frame: From the first visit to definitive crown placement
Analyze how much time are needed to make monolithic zirconia single posterior implant supported crowns to assess economic profitability of theses crowns
3 secondary outcomes
Functional Implant Prosthetic Score (FIPS)
Time frame: 1 week post-op to 1 year follow up
Patient Related Outcome Measures (PROMs)
Time frame: 1 week post-op to 1 year follow up
Accuracy
Time frame: Prosthetic Baseline to Definitive Crown Placement
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 7 Mar 2025.
- BackgroundBrånemark PI, Zarb G, Albrektsson T, editors. Chicago: : Quintessence Publishing; 1985. Tissue-integrated prostheses: Osseointegration in clinical dentistry
- Background: PubMed 12146526Mayer TM, Hawley CE, Gunsolley JC, Feldman S. The single-tooth implant: a viable alternative for single-tooth replacement. J Periodontol. 2002 Jul;73(7):687-93. doi: 10.1902/jop.2002.73.7.687.
- Background: PubMed 17209794Levin L, Sadet P, Grossmann Y. A retrospective evaluation of 1,387 single-tooth implants: a 6-year follow-up. J Periodontol. 2006 Dec;77(12):2080-3. doi: 10.1902/jop.2006.060220.
- Background: PubMed 9715010Muftu A, Chapman RJ. Replacing posterior teeth with freestanding implants: four-year prosthodontic results of a prospective study. J Am Dent Assoc. 1998 Aug;129(8):1097-102. doi: 10.14219/jada.archive.1998.0384.
- Background: PubMed 10328659Schwartz-Arad D, Samet N, Samet N. Single tooth replacement of missing molars: a retrospective study of 78 implants. J Periodontol. 1999 Apr;70(4):449-54. doi: 10.1902/jop.1999.70.4.449.
- BackgroundJung SW, Lee JK, Um HS, Chang BS. A retrospective study on survival rate of the most posterior single tooth implant. J Korean Acad Periodontol. 2008;38:611-620.
- Background: PubMed 19885435Salvi GE, Bragger U. Mechanical and technical risks in implant therapy. Int J Oral Maxillofac Implants. 2009;24 Suppl:69-85.
- Background: PubMed 17002743De Boever AL, Keersmaekers K, Vanmaele G, Kerschbaum T, Theuniers G, De Boever JA. Prosthetic complications in fixed endosseous implant-borne reconstructions after an observations period of at least 40 months. J Oral Rehabil. 2006 Nov;33(11):833-9. doi: 10.1111/j.1365-2842.2006.01638.x.
- Background: PubMed 15101598Vigolo P, Givani A, Majzoub Z, Cordioli G. Cemented versus screw-retained implant-supported single-tooth crowns: a 4-year prospective clinical study. Int J Oral Maxillofac Implants. 2004 Mar-Apr;19(2):260-5.
- Background: PubMed 17190302Nedir R, Bischof M, Szmukler-Moncler S, Belser UC, Samson J. Prosthetic complications with dental implants: from an up-to-8-year experience in private practice. Int J Oral Maxillofac Implants. 2006 Nov-Dec;21(6):919-28.
- Background: PubMed 11168268Bragger U, Aeschlimann S, Burgin W, Hammerle CH, Lang NP. Biological and technical complications and failures with fixed partial dentures (FPD) on implants and teeth after four to five years of function. Clin Oral Implants Res. 2001 Feb;12(1):26-34. doi: 10.1034/j.1600-0501.2001.012001026.x.
- Background: PubMed 11915544Sethi A, Kaus T, Sochor P, Axmann-Krcmar D, Chanavaz M. Evolution of the concept of angulated abutments in implant dentistry: 14-year clinical data. Implant Dent. 2002;11(1):41-51. doi: 10.1097/00008505-200201000-00013.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monolithic Zirconia Posterior Single Screw Retained Implant Crowns in people with Posterior Single Edentulous Sites, run by University of Barcelona at 1 site in Spain.
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 4 inclusion and 4 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 7 Mar 2025. 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 Spain. 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?
Cost (time frame: From the first visit to definitive crown placement). The study lists 2 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 NCT06865209, which also lists 33 linked publications.
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 7 Mar 2025.