Clinical Performance of Chairside CAD/CAM Restorations

Not Applicable

Completed

Conditions: Dental Cements
Caries,Dental

Interventions: Device: Lithium disilicate onlays (IPS emaxCAD/Ivoclar)
Device: Chairside zirconia crowns (3M)

Registration Number: NCT04279574

Lead Sponsor: Solventum US LLC

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 58

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAD/CAM Onlays	Lithium disilicate onlays (IPS emaxCAD/Ivoclar)	Lithium disilicate chairside CAD/CAM onlays (IPS emaxCAD/Ivoclar) will be adhesively bonded using a selective enamel etch technique with an adhesive (3M) and cement (3M).
CAD/CAM Crowns	Chairside zirconia crowns (3M)	Full contour zirconia crowns (3M Chairside Zirconia/3M) will be cemented using a self-adhesive cement (3M).

Primary Outcome Measures

Name	Time	Method
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Retention Scores]	3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years	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.\]

Secondary Outcome Measures

Name	Time	Method
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Material Fracture Scores]	3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years	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.\]
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Point - Distal Scores]	3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years	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.\]
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Form - Mesial]	3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years	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.\]
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Point - Mesial Scores]	3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years	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.\]
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Form - Distal Scores]	3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years	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.\]
Biologic Properties of Restorations (Onlays and Crowns) [Recurrence of Caries, Erosion, Abfraction Scores]	3 years with assessments at 6 months, 1 year, 2 years, and 3 years	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.\]
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Occlusal Contour and Wear Scores]	3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years	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.\]
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Marginal Adaptation Scores]	3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years	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.\]
Short-term Post-operative Sensitivity (Onlays and Crowns)	up to 4 weeks after baseline with weekly assessments or until the restoration is reported asymptomatic	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.
Esthetic Properties of Restorations (Onlays and Crowns) [Surface Luster Scores]	3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years	Surface Luster: Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) \[1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor\]
Gingival Index (Onlays and Crowns)	3 years with assessments at 6 months, 1 year, 2 years, and 3 years	Loe \& Silness Index, 1963 \[0: normal gingiva, 1: mild inflammation and no bleeding, 2: moderate inflammation and bleeding, 3: severe inflammation\]
Plaque Index (Onlays and Crowns)	3 years with assessments at 6 months, 1 year, 2 years, and 3 years	Silness \& Loe Index, 1964 \[0: plaque detectable in the gingival area, 1: plaque recognized only by running tip of probe across tooth surface at gingival crest, 2: moderate accumulation of plaque visible along gingival margin and adjacent tooth, 3: abundance of plaque visible along gingival margin and adjacent tooth\]
Esthetic Properties Clinical Performance of Restorations (Onlays and Crowns) [Aesthetic Anatomical Form]	3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years	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\]
Biologic Properties of Restorations (Onlays and Crowns) [Post-operative Sensitivity]	3 years with assessments at 6 months, 1 year, 2 years, and 3 years	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.\]
Esthetic Properties of Restorations (Onlays and Crowns) [Surface Staining Scores]	3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years	Surface Staining: Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) \[1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor\]
Esthetic Properties of Restorations (Onlays and Crowns) [Margin Staining Scores]	3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years	Margin Staining: Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) \[1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor\]
Esthetic Properties of Restorations (Onlays and Crowns) [Color Match and Translucency Scores]	3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years	Color Match and Translucency: Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) \[1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor\]
Esthetic Properties of Restorations (Onlays and Crowns) [Aesthetic Anatomical Form Scores]	3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years	Aesthetic anatomical form: Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) \[1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor\]