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

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

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.

Study Overview

• Status: Unknown
• Conditions: Survival; Success; CDA Index
• Intervention / Treatment: Device: prosthetic crowns

• Study Type: Interventional
• Enrollment (Anticipated): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • SI
    • Siena, SI, Italy, 53100
      • Department of Dental Materials and Fixed Prosthodontics of Siena, Tuscan School of Dental Medicine, University of Florence and Siena, Siena, Italy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: prosthesis; 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; prosthetic crowns

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Siena

Publications and helpful links

General Publications

• Cagidiaco EF, Grandini S, Goracci C, Joda T. A pilot trial on lithium disilicate partial crowns using a novel prosthodontic functional index for teeth (FIT). BMC Oral Health. 2019 Dec 9;19(1):276. doi: 10.1186/s12903-019-0957-4.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Anticipated): September 1, 2015
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: April 5, 2013
• First Submitted That Met QC Criteria: April 16, 2013
• First Posted (Estimate): April 19, 2013

Study Record Updates

• Last Update Posted (Estimate): July 8, 2014
• Last Update Submitted That Met QC Criteria: July 4, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: zirconia; crown; IPS e.max CAD
• Other Study ID Numbers: T-158; T-158s (Registry Identifier: T-158s)