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.
A wide variety of restorative materials are available for dental restorations. The most popular current materials include glass ceramics and full contour zirconia. Glass ceramic materials are generally preferred for their high translucency mimicking enamel-like esthetics of natural teeth and zirconia is preferred for high strength applications. Both of these materials are available for clinical treatment using chairside CAD/CAM technology. The introduction of an induction sintering oven (SpeedFire oven/Dentsply Sirona) opened the opportunity for chairside full contour zirconia crowns by decreasing sintering times for zirconia to under 30 minutes. 3M Chairside Zirconia (3M) was marketed in 2019 and offers improved esthetics and high strength for monolithic zirconia restorations with an efficient processing time. This investigation will be a longitudinal clinical trial to study the long-term clinical performance of CAD/CAM restorations. Lithium disilicate chairside CAD/CAM onlays (IPS emaxCAD/Ivoclar) will be adhesively bonded using a selective enamel etch technique with a universal adhesive (3M) and a resin cement (3M). Full contour zirconia crowns (3M Chairside Zirconia/3M) will be cemented using a self-adhesive technique.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Restoration of posterior teeth
Restoration of posterior teeth
University of Michigan
Ann Arbor, Michigan, United States
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Retention Scores]
Retention. Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) \[5b.1 Restoration in place; 5b.5 Complete loss of restoration\] Functional property (retention) assessed by visual and/or tactile assessment by two independent examiners.\]
Time frame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Material Fracture Scores]
Material Fracture. Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) \[1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor\] Functional properties assessed by visual and/or tactile assessment by two independent examiners.\]
Time frame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Form - Mesial]
Approximal anatomical contact form - mesial. Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) \[1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor\] Functional property assessed by visual and/or tactile assessment by two independent examiners.\]
Time frame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Point - Mesial Scores]
Approximal anatomical contact point - mesial. Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) \[1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor\] Functional property assessed by visual and/or tactile assessment by two independent examiners.\]
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Time frame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Form - Distal Scores]
Approximal Anatomical Contact Form - Distal. Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) \[1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor\] Functional property assessed by visual and/or tactile assessment by two independent examiners.\]
Time frame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Point - Distal Scores]
Approximal Anatomical Contact Point - Distal. Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) \[1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor\] Functional property assessed by visual and/or tactile assessment by two independent examiners.\]
Time frame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Occlusal Contour and Wear Scores]
Occlusal contour and wear. Evaluations according to FDI World Dental Federation critera (Hickel et al., 2010) \[1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor\] Functional property assessed by visual and/or tactile assessment by two independent examiners.\]
Time frame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Biologic Properties of Restorations (Onlays and Crowns) [Recurrence of Caries, Erosion, Abfraction Scores]
Recurrence of caries, erosion, abfraction. Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) \[1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor\] Biological properties assessed by visual and/or tactile assessment by two independent examiners.\]
Time frame: 3 years with assessments at 6 months, 1 year, 2 years, and 3 years
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Marginal Adaptation Scores]
Marginal Adaptation. Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) \[1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor\] Functional property assessed by visual and/or tactile assessment by two independent examiners.\]
Time frame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Esthetic Properties of Restorations (Onlays and Crowns) [Surface Luster Scores]
Surface Luster: Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) \[1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor\]
Time frame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Short-term Post-operative Sensitivity (Onlays and Crowns)
Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) \[Rating Scale 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor\] Biological properties assessed by patient interview.
Time frame: up to 4 weeks after baseline with weekly assessments or until the restoration is reported asymptomatic
Gingival Index (Onlays and Crowns)
Loe \& Silness Index, 1963 \[0: normal gingiva, 1: mild inflammation and no bleeding, 2: moderate inflammation and bleeding, 3: severe inflammation\]
Time frame: 3 years with assessments at 6 months, 1 year, 2 years, and 3 years
Plaque Index (Onlays and Crowns)
Silness \& Loe Index, 1964 \[0: plaque detectable in the gingival area, 1: plaque recognized only by running tip of probe across tooth surface at gingival crest, 2: moderate accumulation of plaque visible along gingival margin and adjacent tooth, 3: abundance of plaque visible along gingival margin and adjacent tooth\]
Time frame: 3 years with assessments at 6 months, 1 year, 2 years, and 3 years
Esthetic Properties Clinical Performance of Restorations (Onlays and Crowns) [Aesthetic Anatomical Form]
Aesthetic Anatomical Form. Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) \[1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor\] Functional property assessed by visual and/or tactile assessment by two independent examiners\]
Time frame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Biologic Properties of Restorations (Onlays and Crowns) [Post-operative Sensitivity]
Post-operative sensitivity. Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) \[1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor\] Biological properties assessed by patient interview.\]
Time frame: 3 years with assessments at 6 months, 1 year, 2 years, and 3 years
Esthetic Properties of Restorations (Onlays and Crowns) [Surface Staining Scores]
Surface Staining: Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) \[1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor\]
Time frame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Esthetic Properties of Restorations (Onlays and Crowns) [Margin Staining Scores]
Margin Staining: Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) \[1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor\]
Time frame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Esthetic Properties of Restorations (Onlays and Crowns) [Color Match and Translucency Scores]
Color Match and Translucency: Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) \[1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor\]
Time frame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Esthetic Properties of Restorations (Onlays and Crowns) [Aesthetic Anatomical Form Scores]
Aesthetic anatomical form: Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) \[1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor\]
Time frame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years