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Recruiting NCT01974362

Monolithic Zirconia Full-Mouth Implant Supported Rehabilitation Behavior

Observational Endosseous Dental Implant Failure Accident Caused by Broken Ceramic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dental Implant, Monolithic Zirconia (MZ), Zirconia-Feldspathic (PVZ), Monolithic Zirconia (FCMZ).
Who it may be relevant to
Registry conditions: Endosseous Dental Implant Failure, Accident Caused by Broken Ceramic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Portugal
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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 ?

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.

Interventions

  • Device Dental Implant
    Place dental implants in both jaws (maxilla and mandible) according to manufacturer specifications
  • Device Monolithic Zirconia (MZ)
    rehabilitation with monolithic zirconia implant-prosthesis with bucal feldspathic veneer
  • Device Zirconia-Feldspathic (PVZ)
    restore dental implants with a zirconia suprastructure and feldspathic veneers
  • Device Monolithic Zirconia (FCMZ)
    Full contour full arch zirconia rehabilitation

Primary outcome measures

  • Total Amount of Chipping [Time frame: at least 1-Year post-insertion]
  • Number of Small Complications [Time frame: at least 1-year post-insertion]
  • Number of Big Complications [Time frame: at least 1-Year post Insertion]
  • Number of prosthesis failures [Time frame: at least 1-year post insertion]
Secondary outcome measures (1)
  • Biological complications [Time frame: at least 1-Year post insertion]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Portugal · 1 center
  • Artur Simões — Lisbon

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. PMID 30521106

Identifiers

NCT: NCT01974362 · II-06

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗