Clinical Performance of Chairside CAD/CAM Restorations

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Performance of Chairside CAD/CAM Restorations

Conditions
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Dental Cements, Caries,Dental

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CAD/CAM Onlays<br>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). | Device: Lithium disilicate onlays (IPS emaxCAD/Ivoclar)<br>* Restoration of posterior teeth<br>|
| Other: CAD/CAM Crowns<br>Full contour zirconia crowns (3M Chairside Zirconia/3M) will be cemented using a self-adhesive cement (3M). | Device: Chairside zirconia crowns (3M)<br>* Restoration of posterior teeth<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional long-term properties clinical performance of restorations (onlays and crowns) [Change from baseline] | Evaluations according to FDI criteria (Hickel et al., 2010) [1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor] Functional properties (anatomical form, material fracture, retention, margin adaptation, occlusal contour and wear, proximal contact and contour); visual and/or tactile assessment by two independent examiners, patient interview] | 3 years | 
| Esthetic properties of restorations (onlays and crowns) [Change from baseline] | Evaluations according to FDI criteria (Hickel et al., 2010) [1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor] Esthetic properties (surface luster, surface staining, margin staining, color match, translucency) | 3 years | 
| Biologic properties of restorations (onlays and crowns) [Change from baseline] | Evaluations according to FDI criteria (Hickel et al., 2010) [1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor] Biological properties (post-operative sensitivity, recurrence of caries, erosion, abfraction); visual and/or tactile assessment by two independent examiners, patient interview] | 3 years | 
| Short-term post-operative sensitivity [Change from baseline] | Rating scale [1: No sensitivity, 2: Slight sensitivity, 3: Moderate sensitivity, 4: Severe discomfort] | up to 4 weeks after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingival index | Loe & Silness Index, 1963 [0: normal gingiva, 1: mild inflammation and no bleeding, 2: moderate inflammation and bleeding, 3: severe inflammation] | 3 years | 
| Plaque index | 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] | 3 years |