Monolithic Zirconia Full-Mouth Implant Supported Rehabilitation Behavior

April 28, 2026 updated by: Implantology Institute
In patients that did a full mouth implant supported rehabilitation does Cad/Cam Monolithic Zirconia compared to Cad/Cam Zirconia Suprastructure (zirconium oxide (Yttrium - partially stabilized with tetragonal polycrystalline structure) veneered with feldspathic ceramic, has less post-insertion complications after at least 1-Year follow-up ?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
    • Lisbon District
      • Lisbon, Lisbon District, Portugal, 1070-061
        • Recruiting
        • Artur Simões
        • Sub-Investigator:
          • Andre Moreira, Phd
        • Contact:
        • Sub-Investigator:
          • Pedro Crispim, Msc
        • Sub-Investigator:
          • Helena Francisco, Phd
        • Sub-Investigator:
          • Duarte Marques, Phd
        • Principal Investigator:
          • Artur Simões, Msc
        • Principal Investigator:
          • João Caramês, Phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • the presence of any systemic disease or condition that could compromise postoperative healing or osseointegration.
  • Not full mouth rehabilitation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Device: Dental Implant
Place dental implants in both jaws (maxilla and mandible) according to manufacturer specifications
Other Names:
  • Dental Fixtures
Device: Monolithic Zirconia (MZ)
rehabilitation with monolithic zirconia implant-prosthesis with bucal feldspathic veneer
Other Names:
  • Prettau®, Zirkonzhan®
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)
Device: Dental Implant
Place dental implants in both jaws (maxilla and mandible) according to manufacturer specifications
Other Names:
  • Dental Fixtures
Device: Monolithic Zirconia (FCMZ)
Full contour full arch zirconia rehabilitation
Other Names:
  • Prettau®, Zirkonzhan®
Zirconia-Feldspathic (PVZ)
Patients that have a full-mouth (maxilla and/or mandible) implant supported rehabilitation restored with zirconia substructure and feldspathic veneered biomaterial
Device: Dental Implant
Place dental implants in both jaws (maxilla and mandible) according to manufacturer specifications
Other Names:
  • Dental Fixtures
Device: Zirconia-Feldspathic (PVZ)
restore dental implants with a zirconia suprastructure and feldspathic veneers
Other Names:
  • Ice Ceramic ® Zirkonzhan®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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"
at least 1-Year post-insertion
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
at least 1-year post-insertion
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;
at least 1-Year post Insertion
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
at least 1-year post insertion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biological complications
Time Frame: at least 1-Year post insertion
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
at least 1-Year post insertion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Implantology Institute

Investigators

  • Principal Investigator: Artur Simões, Msc, Implantology Institute
  • Study Director: Duarte Marques, Msc, Implantology Institute
  • Study Director: João Caramês, Phd, Implantology Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

October 26, 2013

First Submitted That Met QC Criteria

October 26, 2013

First Posted (Estimated)

November 1, 2013

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • II-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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