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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Success, Survival, CDA Index

Intervention / Treatment
-----------------
* Device: prosthetic crowns


Participation Criteria
=================
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 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prosthesis<br>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 | Device: prosthetic crowns<br>* prosthetic crowns<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
zirconia, crown, IPS e.max CAD