Are you healthy and looking to help advance medical science?

You may be eligible to participate in a accident caused by broken ceramic clinical study, and could be compensated for your time.

Are you healthy and looking to help advance medical science? You may be eligible to participate in a accident caused by broken ceramic clinical study, and could be compensated for your time.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Accident Caused by Broken Ceramic Clinical Trial in Lisbon

NCT01974362 | Observational

Are you healthy and looking to help advance medical science?

You may be eligible to participate in a accident caused by broken ceramic clinical study, and could be compensated for your time.

Are you healthy and looking to help advance medical science? You may be eligible to participate in a accident caused by broken ceramic clinical study, and could be compensated for your time.

Recruiting

Male & Female

18 Years +

This study is looking to recruit 90 Participants

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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Details for the 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

Brief Title

Monolithic Zirconia Full-Mouth Implant Supported Rehabilitation Behavior

Official Title

Monolithic Zirconia Full-Mouth Implant Supported Rehabilitation Behavior

Brief Summary

In patients that did a full mouth implant supported rehabilitation does Cad/Cam Monolithic <br /> Zirconia compared to Cad/Cam Zirconia Suprastructure (zirconium oxide (Yttrium - partially <br /> stabilized with tetragonal polycrystalline structure) veneered with feldspathic ceramic, has <br /> 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.

Treatments and/or Procedures

Monolithic zirconia FCMZ

Full contour full arch zirconia rehabilitation

Dental implant

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

Monolithic zirconia MZ

rehabilitation with monolithic zirconia implant-prosthesis with bucal feldspathic veneer

Zirconia Feldspathic (PVZ)

restore dental implants with a zirconia suprastructure and feldspathic veneers

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

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;

at least 1-Year post Insertion

Primary

Number of prosthesis failures

a "Delta" classification will be attributed when fracture of the framework is present, defining a non-surviving prosthesis

at least 1-year post insertion

Primary

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"

at least 1-Year post-insertion

Primary

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

at least 1-year post-insertion

Secondary

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

at least 1-Year post insertion

Study 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