CDA Index, Success, Survival
Conditions
Keywords
zirconia, crown, IPS e.max CAD
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.
Interventions
DEVICEprosthetic crowns
prosthetic crowns
Sponsors
University of Siena
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| success of Porcelain-fused and IPS e.Max CAD Crowns | 5 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| survival of Porcelain-fused and IPS e.Max CAD Crowns | 5 years | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| CDA index | 5 years | California Dental Association. Quality Evaluation for Dental Care. Guidelines for the Assessment of Clinical Quality and Professional Performance. Los Angeles: CDA, 1977. |
Countries
Italy
Outcome results
None listed