Clinical Study of Porcelain-fused and IPS e.Max CAD Crowns

Survival Clinical Trial

Official title:

A Clinical Evaluation of Hand-veneered, Porcelain-fused NobelProcera(TM) Crown Shaded Zirconia and NobelProcera(TM) Full Contour Crown IPS e.Max CAD on Molars

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01835821
• Other study ID #: T-158
• Secondary ID: T-158s
• Status: Active, not recruiting
• Phase: N/A
• First received: April 5, 2013
• Last updated: July 4, 2014
• Start date: March 2010
• Est. completion date: March 2016

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

This clinical study has the objective to compare the longevity and the clinical behaviour (CDA Index, soft tissue behavior, success and survival rates) of single cemented ceramic crowns made with shaded zirconia (NobelProceraTM Shaded Zirconia) and NobelProceraTM full contour crowns IPS e.max CAD lithium disilicate on molars.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 11
• Est. completion date: March 2016
• Est. primary completion date: September 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 at least two paired contalateral single-tooth full coverage molar restorations in the maxilla and/or mandible.

• The subject shall have a stable occlusal relationship with a fully restored, fixed opposing dentition.

• Obtained informed consent from the subject.

• 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 is 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

• CDA Index
• Success
• Survival

Intervention

Device:
• prosthetic crowns
prosthetic crowns

Locations

Country	Name	City	State
Italy	Department of Dental Materials and Fixed Prosthodontics of Siena, Tuscan School of Dental Medicine, University of Florence and Siena, Siena, Italy	Siena	SI

Sponsors (1)

Lead Sponsor	Collaborator
University of Siena

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	CDA index	California Dental Association. Quality Evaluation for Dental Care. Guidelines for the Assessment of Clinical Quality and Professional Performance. Los Angeles: CDA, 1977.	5 years	No
Primary	success of Porcelain-fused and IPS e.Max CAD Crowns	A "successful crown" is when the CDA index (Marginal integrity, Color match, Surface texture and Anatomic form) shall be Romeo or Sierra (excellent or acceptable) at delivery and remain so during the study period.	5 years	No
Secondary	survival of Porcelain-fused and IPS e.Max CAD Crowns	A "surviving crown" is when the crown remains in occlusion, and when the subject's treatment is functionally successful even though all the individual success criteria are not fulfilled.	5 years	No