Clinical Study on Zirconia Bridges

Missing Teeth Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01835834
• Other study ID #: T-159
• Status: Active, not recruiting
• Phase: N/A
• First received: April 5, 2013
• Last updated: July 4, 2014
• Start date: January 2010
• Est. completion date: December 2015

Study information

• Verified date: July 2014
• Source: University of Siena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 9
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anodontia
• Missing Teeth
• Tooth Loss

Intervention

Procedure:
• zirconia bridge restoration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Siena

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival rate of NobelProcera™ Bridge Shaded Zirconia	Success and Failure Criteria The CDA index will be used for the success criteria in this investigation. Please see also the criteria in the "clinical parameter" part of this protocol.; The success and failure criteria to be used in this investigation have been determined as follows: A successful NobelProcera™ Bridge Shaded Zirconia is when: the CDA index is Romeo or Sierra at delivery and remains so during the study period.; A surviving NobelProcera™ Bridge Shaded Zirconia is when: the restoration is in occlusion and in function, even though all the success criteria are not fulfilled, but is to be regarded as correctable.; A failed NobelProcera™ Bridge Shaded Zirconia is when: the restoration has 1) been removed, 2) fractured, or 3) cannot be classified as a surviving or a successful restoration.	5 years	No