Monolithic Zirconia Full-Mouth Implant Supported Rehabilitation Behavior
1 other identifier
observational
90
1 country
1
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 ?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2013
CompletedFirst Posted
Study publicly available on registry
November 1, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
May 4, 2026
April 1, 2026
14 years
October 26, 2013
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
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
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
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
Secondary Outcomes (1)
Biological complications
at least 1-Year post insertion
Study Arms (3)
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
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)
Zirconia-Feldspathic (PVZ)
Patients that have a full-mouth (maxilla and/or mandible) implant supported rehabilitation restored with zirconia substructure and feldspathic veneered biomaterial
Interventions
Place dental implants in both jaws (maxilla and mandible) according to manufacturer specifications
rehabilitation with monolithic zirconia implant-prosthesis with bucal feldspathic veneer
restore dental implants with a zirconia suprastructure and feldspathic veneers
Full contour full arch zirconia rehabilitation
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- the presence of any systemic disease or condition that could compromise postoperative healing or osseointegration.
- Not full mouth rehabilitation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Artur Simões
Lisbon, Lisbon District, 1070-061, Portugal
Related Publications (1)
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: 30521106RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
João Caramês, Phd
Implantology Institute
- PRINCIPAL INVESTIGATOR
Artur Simões, Msc
Implantology Institute
- STUDY DIRECTOR
Duarte Marques, Msc
Implantology Institute
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2013
First Posted
November 1, 2013
Study Start
January 1, 2014
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
December 31, 2029
Last Updated
May 4, 2026
Record last verified: 2026-04