N/A
Completed N=68
Clinical Performance of Chairside CAD/CAM Restorations
Dental Cements · Caries,Dental
Source: ClinicalTrials.gov NCT04279574 ↗
Enrolled (actual)
68
Serious AEs
1.5%
Results posted
Mar 2025
Primary outcomePrimary: Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Retention Scores] — 40; 40; 0; 0 Restorations
Summary
This investigation will be a longitudinal clinical trial to study the long-term clinical performance of a resin cement for chairside CAD/CAM restorations. Lithium disilicate chairside CAD/CAM onlays will be adhesively bonded using a selective enamel etch technique with an adhesive.
Full contour zirconia crowns will be cemented using a self-adhesive resin cement.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Retention Scores] |
40; 40; 0; 0; 0; 0 | — |
| SECONDARY Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Material Fracture Scores] |
40; 40; 0; 0; 0; 0 | — |
| SECONDARY Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Form - Mesial] |
38; 40; 0; 0; 0; 0 | — |
| SECONDARY Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Point - Mesial Scores] |
38; 40; 0; 0; 0; 0 | — |
| SECONDARY Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Form - Distal Scores] |
29; 25; 0; 0; 0; 0 | — |
| SECONDARY Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Point - Distal Scores] |
29; 25; 0; 0; 0; 0 | — |
| SECONDARY Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Occlusal Contour and Wear Scores] |
40; 40; 0; 0; 0; 0 | — |
| SECONDARY Biologic Properties of Restorations (Onlays and Crowns) [Recurrence of Caries, Erosion, Abfraction Scores] |
40; 40; 0; 0; 0; 0 | — |
| SECONDARY Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Marginal Adaptation Scores] |
40; 40; 0; 0; 0; 0 | — |
| SECONDARY Esthetic Properties of Restorations (Onlays and Crowns) [Surface Luster Scores] |
40; 40; 0; 0; 0; 0 | — |
| SECONDARY Short-term Post-operative Sensitivity (Onlays and Crowns) |
37; 34; 3; 4; 0; 2 | — |
| SECONDARY Gingival Index (Onlays and Crowns) |
40; 40; 0; 0; 0; 0 | — |
| SECONDARY Plaque Index (Onlays and Crowns) |
40; 37; 0; 3; 0; 0 | — |
| SECONDARY Esthetic Properties Clinical Performance of Restorations (Onlays and Crowns) [Aesthetic Anatomical Form] |
40; 40; 0; 0; 0; 0 | — |
| SECONDARY Biologic Properties of Restorations (Onlays and Crowns) [Post-operative Sensitivity] |
40; 39; 0; 1; 0; 0 | — |
| SECONDARY Esthetic Properties of Restorations (Onlays and Crowns) [Surface Staining Scores] |
40; 40; 0; 0; 0; 0 | — |
| SECONDARY Esthetic Properties of Restorations (Onlays and Crowns) [Margin Staining Scores] |
40; 40; 0; 0; 0; 0 | — |
| SECONDARY Esthetic Properties of Restorations (Onlays and Crowns) [Color Match and Translucency Scores] |
40; 40; 0; 0; 0; 0 | — |
| SECONDARY Esthetic Properties of Restorations (Onlays and Crowns) [Aesthetic Anatomical Form Scores] |
40; 40; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Subject in need of crown and/or onlay restoration
- Subject age 18 or above
- Subject with healthy / treated periodontal status (max. degree of movement 1)
- Subject agrees to participate in the study and signed informed consent and HIPAA form
Exclusion Criteria
- Devital or sensitive teeth
- Teeth diagnosed with symptoms of incomplete tooth fracture
- Teeth with prior endodontic treatment of any kind
- Teeth with a history of direct or indirect pulp capping procedures
- Subjects with uncontrolled bruxism or parafunctional habits
- Subject has known allergies to any product used in this study
- Subject will not be available for the study duration
- Subjects with significant untreated dental disease to include periodontitis and rampant caries
- Pregnant or lactating women
Data sourced from ClinicalTrials.gov (NCT04279574). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.