Endosseous Dental Implant FailureNCT01974362
Monolithic Zirconia Full-Mouth Implant Supported Rehabilitation Behavior
An observational study of Endosseous Dental Implant Failure and Accident Caused by Broken Ceramic, run by Implantology Institute at 1 site in Portugal.
Trial summary
In patients rehabilitated with a full-arch (maxillary and/or mandibular) implant-supported fixed prosthesis, do three CAD/CAM zirconia framework designs - porcelain-veneered zirconia (PVZ), monolithic zirconia with buccal veneer (MZ) and full-contour monolithic zirconia (FCMZ) - differ in the incidence of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endosseous Dental Implant Failure, Accident Caused by Broken Ceramic
- What is being tested?
- Dental Implant, Monolithic Zirconia (MZ) and Zirconia-Feldspathic (PVZ)
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 sitePortugal
- Study dates
- Jan 2014to 31 Dec 2029
- Phase
- Observational
- 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
Study population: Patients from a dental office that did a full-mouth (bimaxillary - maxilla and/or mandible) implant-supported rehabilitation and made the final rehabilitation with either monolithic zirconia or in feldspathic-zirconia
Who may be able to join
- Maxilla and/or Mandible Implant full-mouth restoration
- Monolithic ceramic or zirconia-feldspathic restoration
- be at least 18 years of age;
- present no systemic or local absolute contraindications for endosseous implant placement;
- at least 1 Year Follow-up
Who cannot join
- the presence of any systemic disease or condition that could compromise postoperative healing or osseointegration.
- Not full mouth rehabilitation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Artur Simões
Lisbon, Lisbon District, 1070-061
Artur Simões, artursimoes@institutoimplantologia.com
João Caramês, Phd
About this study
In patients rehabilitated with a full-arch (maxillary and/or mandibular) implant-supported fixed prosthesis, do three CAD/CAM zirconia framework designs - porcelain-veneered zirconia (PVZ), monolithic zirconia with buccal veneer (MZ) and full-contour monolithic zirconia (FCMZ) - differ in the incidence of post-insertion technical complications, in particular ceramic chipping, and in prosthesis survival and success after at least 1 year in function?
This prospective observational study, conducted in a private clinical setting, compares the three designs regarding technical and biological complications, prosthesis survival and success (Alpha/Bravo/Charlie/Delta classification) and implant success, and examines the influence of arch, number of implants, opposing dentition and cantilever extension on the occurrence of complications.
Read the detailed description
Study the behavior of implant supported rehabilitations made from full-zirconium dioxide (monolithic with buccal veneer (MZ) or full contour monolithic (FCMZ) ) and zirconia veneered with feldspathic (PVZ) in full-mouth type of rehabilitations (maxilla and mandible).
In a private clinic we will record the behavior, regarding prosthodontic and biological complications in different groups (MZ vs FCMZ vs PVZ) after at least 1 year in function.
We will make calibration of the investigators for prosthodontic and biological assessement and accepting an inter-observer agreement (Kappa) of 0.9 for each parameter.
Recording will be made without the help of magnifying utilities such as magnifying glasses or optical microscopes.
- Being tested
- Dental Implant, Monolithic Zirconia (MZ), Zirconia-Feldspathic (PVZ), Monolithic Zirconia (FCMZ)
- Keywords
- Monolithic Zirconia, Zirconia-Feldspathic zirconia, Dental Implants, Fracture, Chipping
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental ImplantDevice
Also called Dental Fixtures
Place dental implants in both jaws (maxilla and mandible) according to manufacturer specifications
Monolithic Zirconia (MZ)Device
Also called Prettau®, Zirkonzhan®
rehabilitation with monolithic zirconia implant-prosthesis with bucal feldspathic veneer
Zirconia-Feldspathic (PVZ)Device
Also called Ice Ceramic ® Zirkonzhan®
restore dental implants with a zirconia suprastructure and feldspathic veneers
Monolithic Zirconia (FCMZ)Device
Also called Prettau®, Zirkonzhan®
Full contour full arch zirconia rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Monolithic Zirconia with Buccal Veneer (MZ) | Patients that have a full-mouth (maxilla and/or mandible) dental implant supported rehabilitation restored with monolithic zirconia biomaterial with buccal veneers Receives: Device: Dental Implant; Device: Monolithic Zirconia (MZ) | |
| Monolithic Zirconia full-contour (FCMZ) | Patients that have a full-mouth (maxilla and/or mandible) dental implant supported rehabilitation restored with monolithic zirconia biomaterial full contour (without veneer) Receives: Device: Dental Implant; Device: Monolithic Zirconia (FCMZ) | |
| Zirconia-Feldspathic (PVZ) | Patients that have a full-mouth (maxilla and/or mandible) implant supported rehabilitation restored with zirconia substructure and feldspathic veneered biomaterial Receives: Device: Dental Implant; Device: Zirconia-Feldspathic (PVZ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Amount of Chipping
measure the total number of ceramic fractures (chipping) visible at naked eye in both groups (monolithic and feldspathic) that happen from insertion (baseline) to last follow-up visit
Primary outcomes are defined as survival and success rates of the final prosthesis.
For evaluation of these outcomes, an analysis variable will be used (Mendez Caramês et al., 2016): if no alterations are present, the prosthesis will be recorded as "Alpha"
Measured: at least 1-Year post-insertion
Number of Small Complications
Measure the total amount of adverse events other than chipping, that made the patient come to the dental office, that happen from insertion (baseline) to last follow up visit
It is determined that if the complication was solved in the dental chair is considered a Small complication/minor chipping - not requiring any intervention besides polishing or recontouring without the need for prosthesis retrieval-"Bravo" classification will be attributed
Measured: at least 1-year post-insertion
Number of Big Complications
Measure the total amount of adverse events other than chipping, that made the patient come to the dental office, that happen from insertion (baseline) to last follow up.
It is determined that if the complication was solved in the dental laboratory is considered a big complication/major chipping - a "Charlie" classification will indicate the occurrence of major chipping, need for prosthesis retrieval and laboratory intervention;
Measured: at least 1-Year post Insertion
Number of prosthesis failures
a "Delta" classification will be attributed when fracture of the framework is present, defining a non-surviving prosthesis
Measured: at least 1-year post insertion
Secondary outcomes (1)
Biological complications
implant success rates will be evaluated; absence of persistent subjective complaints (pain, foreign body sensation, and/ or dysesthesia); absence of peri-implant infection with suppuration; absence of implant mobility; and absence of continuous radiolucency around the implant by previously established methods based on the clinical and radiographic examinations at the yearly visits
Measured: at least 1-Year post insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startJan 2014
- Primary completion1 Jan 2028 (estimated)
- Study completion31 Dec 2029 (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 Endosseous Dental Implant 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Implantology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- João Caramês, Phd, Study director, Implantology InstituteArtur Simões, Msc, Principal investigator, Implantology InstituteDuarte Marques, Msc, Study director, Implantology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974362
- Sponsor's protocol ID
- II-06
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2013
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Carames J, Marques D, Malta Barbosa J, Moreira A, Crispim P, Chen A. Full-arch implant-supported rehabilitations: A prospective study comparing porcelain-veneered zirconia frameworks to monolithic zirconia. Clin Oral Implants Res. 2019 Jan;30(1):68-78. doi: 10.1111/clr.13393. Epub 2018 Dec 30.
PubMed 30521106
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monolithic Zirconia Full-Mouth Implant Supported Rehabilitation Behavior
- ClinicalTrials.gov ID
- NCT01974362
- Acronym / sponsor ID
- II-06
- Keywords
- Monolithic Zirconia, Zirconia-Feldspathic zirconia, Dental Implants, Fracture, Chipping
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Implantology InstituteUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 1 Nov 2013 (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.
In patients rehabilitated with a full-arch (maxillary and/or mandibular) implant-supported fixed prosthesis, do three CAD/CAM zirconia framework designs - porcelain-veneered zirconia (PVZ), monolithic zirconia with buccal veneer (MZ) and full-contour monolithic zirconia (FCMZ) - differ in the incidence of post-insertion technical complications, in particular ceramic chipping, and in prosthesis survival and success after at least 1 year in function?
This prospective observational study, conducted in a private clinical setting, compares the three designs regarding technical and biological complications, prosthesis survival and success (Alpha/Bravo/Charlie/Delta classification) and implant success, and examines the influence of arch, number of implants, opposing dentition and cantilever extension on the occurrence of complications.
Detailed description
Study the behavior of implant supported rehabilitations made from full-zirconium dioxide (monolithic with buccal veneer (MZ) or full contour monolithic (FCMZ) ) and zirconia veneered with feldspathic (PVZ) in full-mouth type of rehabilitations (maxilla and mandible).
In a private clinic we will record the behavior, regarding prosthodontic and biological complications in different groups (MZ vs FCMZ vs PVZ) after at least 1 year in function.
We will make calibration of the investigators for prosthodontic and biological assessement and accepting an inter-observer agreement (Kappa) of 0.9 for each parameter.
Recording will be made without the help of magnifying utilities such as magnifying glasses or optical microscopes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Monolithic Zirconia with Buccal Veneer (MZ) | – | Device: Dental Implant, Device: Monolithic Zirconia (MZ)Patients that have a full-mouth (maxilla and/or mandible) dental implant supported rehabilitation restored with monolithic zirconia biomaterial with buccal veneers |
| Monolithic Zirconia full-contour (FCMZ) | – | Device: Dental Implant, Device: Monolithic Zirconia (FCMZ)Patients that have a full-mouth (maxilla and/or mandible) dental implant supported rehabilitation restored with monolithic zirconia biomaterial full contour (without veneer) |
| Zirconia-Feldspathic (PVZ) | – | Device: Dental Implant, Device: Zirconia-Feldspathic (PVZ)Patients that have a full-mouth (maxilla and/or mandible) implant supported rehabilitation restored with zirconia substructure and feldspathic veneered biomaterial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from a dental office that did a full-mouth (bimaxillary - maxilla and/or mandible) implant-supported rehabilitation and made the final rehabilitation with either monolithic zirconia or in feldspathic-zirconia
Key inclusion criteria (5 listed)
- Maxilla and/or Mandible Implant full-mouth restoration
- Monolithic ceramic or zirconia-feldspathic restoration
- be at least 18 years of age;
- present no systemic or local absolute contraindications for endosseous implant placement;
- at least 1 Year Follow-up
Key exclusion criteria (2 listed)
- the presence of any systemic disease or condition that could compromise postoperative healing or osseointegration.
- Not full mouth rehabilitation
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 |
|---|---|---|
| Dental ImplantAlso: Dental FixturesPlace dental implants in both jaws (maxilla and mandible) according to manufacturer specifications | Device | Monolithic Zirconia full-contour (FCMZ), Monolithic Zirconia with Buccal Veneer (MZ), Zirconia-Feldspathic (PVZ) |
| Monolithic Zirconia (MZ)Also: Prettau®, Zirkonzhan®rehabilitation with monolithic zirconia implant-prosthesis with bucal feldspathic veneer | Device | Monolithic Zirconia with Buccal Veneer (MZ) |
| Zirconia-Feldspathic (PVZ)Also: Ice Ceramic ® Zirkonzhan®restore dental implants with a zirconia suprastructure and feldspathic veneers | Device | Zirconia-Feldspathic (PVZ) |
| Monolithic Zirconia (FCMZ)Also: Prettau®, Zirkonzhan®Full contour full arch zirconia rehabilitation | Device | Monolithic Zirconia full-contour (FCMZ) |
Primary outcome
Total Amount of Chipping
Time frame: at least 1-Year post-insertion
measure the total number of ceramic fractures (chipping) visible at naked eye in both groups (monolithic and feldspathic) that happen from insertion (baseline) to last follow-up visit Primary outcomes are defined as survival and success rates of the final prosthesis. For evaluation of these outcomes, an analysis variable will be used (Mendez Caramês et al., 2016): if no alterations are present, the prosthesis will be recorded as "Alpha"
Number of Small Complications
Time frame: at least 1-year post-insertion
Measure the total amount of adverse events other than chipping, that made the patient come to the dental office, that happen from insertion (baseline) to last follow up visit It is determined that if the complication was solved in the dental chair is considered a Small complication/minor chipping - not requiring any intervention besides polishing or recontouring without the need for prosthesis retrieval-"Bravo" classification will be attributed
Number of Big Complications
Time frame: at least 1-Year post Insertion
Measure the total amount of adverse events other than chipping, that made the patient come to the dental office, that happen from insertion (baseline) to last follow up. It is determined that if the complication was solved in the dental laboratory is considered a big complication/major chipping - a "Charlie" classification will indicate the occurrence of major chipping, need for prosthesis retrieval and laboratory intervention;
Number of prosthesis failures
Time frame: at least 1-year post insertion
a "Delta" classification will be attributed when fracture of the framework is present, defining a non-surviving prosthesis
1 secondary outcome
Biological complications
Time frame: at least 1-Year post insertion
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 Oct 2026.
- Results publication: PubMed 30521106Carames J, Marques D, Malta Barbosa J, Moreira A, Crispim P, Chen A. Full-arch implant-supported rehabilitations: A prospective study comparing porcelain-veneered zirconia frameworks to monolithic zirconia. Clin Oral Implants Res. 2019 Jan;30(1):68-78. doi: 10.1111/clr.13393. Epub 2018 Dec 30.
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Full-Contour Monolithic Zirconia Full-Mouth Implant Supported Rehabilitation Behavior
Endosseous Dental Implant Failure, Accident Caused by Broken Ceramic
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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.
João Caramês, Phd study director
Implantology Institute
Artur Simões, Msc principal investigator
Implantology Institute
Duarte Marques, Msc study director
Implantology Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endosseous Dental Implant Failure and Accident Caused by Broken Ceramic, run by Implantology Institute at 1 site in Portugal.
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 5 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 15 Oct 2026. 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 Portugal. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Amount of Chipping (time frame: at least 1-Year post-insertion). The study lists 4 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 NCT01974362, 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 Oct 2026.