Monolithic Zirconia Full-Mouth Implant Supported Rehabilitation Behavior

NCT ID: NCT01974362

Last Updated: 2024-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Endosseous Dental Implant Failure Accident Caused by Broken Ceramic

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Dental Implant

Intervention Type DEVICE

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

Monolithic Zirconia (MZ)

Intervention Type DEVICE

rehabilitation with monolithic zirconia implant-prosthesis with bucal feldspathic veneer

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)

Dental Implant

Intervention Type DEVICE

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

Monolithic Zirconia (FCMZ)

Intervention Type DEVICE

Full contour full arch zirconia rehabilitation

Zirconia-Feldspathic (PVZ)

Patients that have a full-mouth (maxilla and/or mandible) implant supported rehabilitation restored with zirconia substructure and feldspathic veneered biomaterial

Dental Implant

Intervention Type DEVICE

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

Zirconia-Feldspathic (PVZ)

Intervention Type DEVICE

restore dental implants with a zirconia suprastructure and feldspathic veneers

Interventions

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Dental Implant

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

Intervention Type DEVICE

Monolithic Zirconia (MZ)

rehabilitation with monolithic zirconia implant-prosthesis with bucal feldspathic veneer

Intervention Type DEVICE

Zirconia-Feldspathic (PVZ)

restore dental implants with a zirconia suprastructure and feldspathic veneers

Intervention Type DEVICE

Monolithic Zirconia (FCMZ)

Full contour full arch zirconia rehabilitation

Intervention Type DEVICE

Other Intervention Names

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Dental Fixtures Prettau®, Zirkonzhan® Ice Ceramic ® Zirkonzhan® Prettau®, Zirkonzhan®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Implantology Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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João Caramês, Phd

Role: STUDY_DIRECTOR

Implantology Institute

Artur Simões, Msc

Role: PRINCIPAL_INVESTIGATOR

Implantology Institute

Duarte Marques, Msc

Role: STUDY_DIRECTOR

Implantology Institute

Locations

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Artur Simões

Lisbon, , Portugal

Site Status RECRUITING

Countries

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Portugal

Facility Contacts

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Artur Simões

Role: primary

References

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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.

Reference Type RESULT
PMID: 30521106 (View on PubMed)

Other Identifiers

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II-06

Identifier Type: -

Identifier Source: org_study_id

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