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NCT Number: NCT01974362

Monolithic Zirconia Full-Mouth Implant Supported Rehabilitation Behavior

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 ?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Artur Simões

Lisbon, Lisbon District, 1070-061, Portugal

Location status: Recruiting

Location contact

Andre Moreira, Phd

SUB_INVESTIGATOR

Artur Simões

CONTACT

[email protected]

Artur Simões, Msc

PRINCIPAL_INVESTIGATOR

Duarte Marques, Phd

SUB_INVESTIGATOR

Helena Francisco, Phd

SUB_INVESTIGATOR

João Caramês, Phd

PRINCIPAL_INVESTIGATOR

Pedro Crispim, Msc

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dental implant

Device

Place dental implants in both jaws (maxilla and mandible) according to manufacturer specifications

Other names: Dental Fixtures

Monolithic Zirconia (MZ)

Device

rehabilitation with monolithic zirconia implant-prosthesis with bucal feldspathic veneer

Other names: Prettau®, Zirkonzhan®

Zirconia-Feldspathic (PVZ)

Device

restore dental implants with a zirconia suprastructure and feldspathic veneers

Other names: Ice Ceramic ® Zirkonzhan®

Monolithic Zirconia (FCMZ)

Device

Full contour full arch zirconia rehabilitation

Other names: Prettau®, Zirkonzhan®

Primary outcomes

  1. 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"

  2. 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

  3. 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;

  4. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Implantology Institute

Other

Registry information

Important dates

Study start
2014
Primary completion
2028
Study completion
2029
First posted
Nov 1, 2013
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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