Monolithic Zirconia Full-Mouth Implant Supported Rehabilitation Behavior

Recruiting

• Conditions: Endosseous Dental Implant Failure; Accident Caused by Broken Ceramic
• Interventions: Device: Dental Implant; Device: Monolithic Zirconia (FCMZ); Device: Zirconia-Feldspathic (PVZ); Device: Monolithic Zirconia (MZ)

• Registration Number: NCT01974362
• Lead Sponsor: Implantology Institute

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.

Study Timeline

• Study First Submitted: 2013-10-26
• Study First Submitted QC: 2013-10-26
• Study First Posted: 2013-11-01
• Study Start: 2014-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-26
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Monolithic Zirconia full-contour (FCMZ)	Monolithic Zirconia (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)	Zirconia-Feldspathic (PVZ)	Patients that have a full-mouth (maxilla and/or mandible) implant supported rehabilitation restored with zirconia substructure and feldspathic veneered biomaterial
Monolithic Zirconia full-contour (FCMZ)	Dental Implant	Patients that have a full-mouth (maxilla and/or mandible) dental implant supported rehabilitation restored with monolithic zirconia biomaterial full contour (without veneer)
Monolithic Zirconia with Buccal Veneer (MZ)	Dental Implant	Patients that have a full-mouth (maxilla and/or mandible) dental implant supported rehabilitation restored with monolithic zirconia biomaterial with buccal veneers
Monolithic Zirconia with Buccal Veneer (MZ)	Monolithic Zirconia (MZ)	Patients that have a full-mouth (maxilla and/or mandible) dental implant supported rehabilitation restored with monolithic zirconia biomaterial with buccal veneers
Zirconia-Feldspathic (PVZ)	Dental Implant	Patients that have a full-mouth (maxilla and/or mandible) implant supported rehabilitation restored with zirconia substructure and feldspathic veneered biomaterial

Primary Outcome Measures

Name	Time	Method
Total Amount of Chipping	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"
Number of Small Complications	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
Number of Big Complications	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;
Number of prosthesis failures	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 Outcome Measures

Name	Time	Method
Biological complications	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

Trial Locations

Locations (1)

Artur Simões; 🇵🇹 Lisboa, Portugal