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

NCT ID: NCT01835821

Last Updated: 2014-07-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2016-03-31

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.

Conditions

Success; Survival; CDA Index

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

prosthetic crowns

Intervention Type: DEVICE

prosthetic crowns

Interventions

prosthetic crowns

prosthetic crowns

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Siena

OTHER

Sponsor Role: lead

Responsible Party

Prof. Marco Ferrari

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Siena, SI, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 31818278 (View on PubMed)

Other Identifiers

T-158s

Identifier Type: REGISTRY

Identifier Source: secondary_id

T-158

Identifier Type: -

Identifier Source: org_study_id