Clinical Study on Zirconia Bridges

NCT ID: NCT01835834

Last Updated: 2014-07-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2015-12-31

Brief Summary

To evaluate the clinical performance and survival rate of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region for a period of 5 years. The working hypothesis of this clinical study is that industrial centrally produced 3- or 4-unit bridges of shaded yttrium-oxide partially-stabilized (Y-TZP) zirconia (NobelProceraTM Shaded Zirconia) in combination with a veneering ceramic material will show sufficient CDA ratings (80% R+S) and a sufficient survival rate (93%) after 5 years in comparison with a reference level of 95%.

Conditions

Missing Teeth

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

zirconia bridge restoration

The device is a ceramic core made of shaded zirconium with an anatomic contour core with a minimum of 0.6 mm** thickness and minimal connector size of 4.0 x 3.0 / 9.4 (height x width [mm] / area [mm2])** of high strength zirconia framework providing homogenous veneering material thickness as an external coating with 1.0 - 2.0 mm* wall thickness. The core is veneered with dental porcelain at the dental laboratory.

Intended use and indications:

NobelProceraTM Bridge Shaded Zirconia consists of an individualized, supporting substructure in a ceramic bridge construction for tooth/teeth replacement.

NobelProceraTM Bridge Zirconia is intended for patients in need of prosthetic oral reconstruction in order to restore chewing function. Zirconia bridges for natural tooth restorations are customized, designed, and milled from pre-sintered blanks of zirconia. The multi-unit restorations can be placed in all positions in the mouth.

Group Type: EXPERIMENTAL

zirconia bridge restoration

Intervention Type: PROCEDURE

Interventions

zirconia bridge restoration

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

The subject must be at least 18 (or age of consent), and less than 70 at the time of inclusion.

• The subject is healthy and compliant with good oral hygiene
• The subject is in need of a posterior fixed partial denture restoration of up to 4 units distal of the canines in the maxilla or mandible.
• The subject shall have a stable occlusal relationship with a fully restored, fixed opposing dentition.
• Obtained informed consent from the subject the subject should be available for the 5-year term of the investigation.
• No apical disorder or inflammation of abutment teeth, adjacent and opposing teeth.
• Good gingival / periodontal / periapical status of restoring, opposing and adjacent teeth. Healed situation of soft tissue augmentation is allowed.
• The subject should be available for the 5-year term of the investigation.

Exclusion Criteria

• The subject is not able to give her/his informed consent to participate.
• Alcohol or drug abuse as noted in patient records or in patient history.
• Reason to believe that the treatment might have a negative effect on the patient's total situation (psychiatric problems), as noted in patient records or in patient history.
• An existing condition where acceptable retention of the restoration is impossible to attain
• Mobility of the tooth to be restored.
• Pathologic pocket formation of 4 mm or greater around the tooth to be restored
• Severe bruxism or other destructive habits
• Amount of attached soft tissue is insufficient (no attached gingiva on the buccal side of the tooth).
• Health conditions, which do not permit the restorative procedure

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Siena

OTHER

Sponsor Role: lead

Responsible Party

Prof. Marco Ferrari

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

T-159

Identifier Type: -

Identifier Source: org_study_id