Clinical trial NCT01835821: Clinical Study of Porcelain-fused and IPS e.Max CAD Crowns
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Success
Survival
CDA Index
Keywords: zirconia
crown
IPS e.max CAD
Lead sponsor: University of Siena
Sponsor class: OTHER
First posted: 2013-04-19
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: success of Porcelain-fused and IPS e.Max CAD Crowns
timeFrame: 5 years
Secondary outcomes:
measure: survival of Porcelain-fused and IPS e.Max CAD Crowns
timeFrame: 5 years
Other outcomes:
measure: CDA index
timeFrame: 5 years
Locations:
city: Siena
country: Italy
facility: Department of Dental Materials and Fixed Prosthodontics of Siena, Tuscan School of Dental Medicine, University of Florence and Siena, Siena, Italy
state: SI
Study officials:
References:
citation: 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.