Clinical trial NCT01974362: Monolithic Zirconia Full-Mouth Implant Supported Rehabilitation Behavior
Official title: Monolithic Zirconia Full-Mouth Implant Supported Rehabilitation Behavior
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endosseous Dental Implant Failure
Accident Caused by Broken Ceramic
Keywords: Monolithic Zirconia
Zirconia-Feldspathic zirconia
Dental Implants
Fracture
Chipping
Lead sponsor: Implantology Institute
Sponsor class: OTHER
First posted: 2013-11-01
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

Brief summary: 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.

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

Primary outcomes:
measure: Total Amount of Chipping
timeFrame: at least 1-Year post-insertion
measure: Number of Small Complications
timeFrame: at least 1-year post-insertion
measure: Number of Big Complications
timeFrame: at least 1-Year post Insertion
measure: Number of prosthesis failures
timeFrame: at least 1-year post insertion
Secondary outcomes:
measure: Biological complications
timeFrame: at least 1-Year post insertion
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Artur Simões
Study officials:
affiliation: Implantology Institute
name: João Caramês, Phd
role: STUDY_DIRECTOR
affiliation: Implantology Institute
name: Artur Simões, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Implantology Institute
name: Duarte Marques, Msc
role: STUDY_DIRECTOR
References:
citation: 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.