Monolithic Zirconia Full-Mouth Implant Supported Rehabilitation Behavior

Endosseous Dental Implant Failure Clinical Trial

Official title:

Monolithic Zirconia Full-Mouth Implant Supported Rehabilitation Behavior

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01974362
• Other study ID #: II-06
• Status: Recruiting
• Start date: January 2014
• Est. completion date: August 1, 2024

Study information

• Verified date: December 2022
• Source: Implantology Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 ?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: August 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Accident Caused by Broken Ceramic
• Endosseous Dental Implant Failure

Intervention

Device:
• 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
• Monolithic Zirconia (FCMZ)
Full contour full arch zirconia rehabilitation

Locations

Country	Name	City	State
Portugal	Artur Simões	Lisboa

Sponsors (1)

Lead Sponsor	Collaborator
Implantology Institute

Country where clinical trial is conducted

Portugal, 

References & 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. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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
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
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