Prospective, randomized clinical split-mouth study investigating the clinical performance of CAD/CAM fabricated partial ceramic crowns inserted with a combination of self-etching adhesive and luting composite (ELX759 / Suglue-10, 3M ESPE, Seefeld) (1) with and (2) without selective enamel etching in comparison to a self-adhesive luting material (RXU2, 3M ESPE, Seefeld)
Not Applicable
- Conditions
- K02Dental caries
- Registration Number
- DRKS00003059
- Lead Sponsor
- DirektorPoliklinik für Zahnerhaltung und ParodontologieKlinikum der Universität Regensburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Vital posterior teeth with extended restorations or lesions with treatment need (partial ceramic crown)
Placement of rubber dam possible
Tooth mobility < 1
No known allergic reactions to compounds of the applied materials
Consent for participation within the study
Consent to participate in recall system over three years
Exclusion Criteria
Bruxism
extensive periodontal lesions
irreversible pain
insufficient oral hygiene (PBI > 35%, API > 35%)
malign tumors, HIV or other general diseases limiting life span
Allergies against compounds of the materials used
Alcohol or drug abuse
Participation in other clinical studies
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The clinical survival of partial ceramic crowns luted to the hard tooth tissues with two luting materials, one applied with and without selective enamel etching, is evaluated. Evaluation is performed at baseline, after 6 months and after 1, 2 and 3 years. Primary outcome is the criterion restoration in situ, must not be renewed (due to technical or biological failures requiring renewal of the restoration)
- Secondary Outcome Measures
Name Time Method The restorations are clinically evaluated according to FDI criteria (2010) at baseline, 6 months, 1, 2 and 3 years with respect to marginal adaptation, marginal discoloration, anatomic form, postoperative hypersensitivities, secondary caries.