Overview

This trial is active, not recruiting.

Conditions success, survival, cda index
Treatment prosthetic crowns
Sponsor University of Siena
Start date March 2010
End date September 2015
Trial size 11 participants
Trial identifier NCT01835821, T-158, T-158s

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
NobelProcera™ Crown shaded zirconia: The device is an individual, ceramic core (figure a) made of shaded zirconium with an anatomic contour providing homogenous veneering material thickness and a minimum core thickness of 0.4 or 0.7mm. The core is veneered with dental porcelain (IPS e.max Ceram) at the dental laboratory
prosthetic crowns
prosthetic crowns

Primary Outcomes

Measure
success of Porcelain-fused and IPS e.Max CAD Crowns
time frame: 5 years

Secondary Outcomes

Measure
survival of Porcelain-fused and IPS e.Max CAD Crowns
time frame: 5 years

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by University of Siena.