Clinical Performance of Chairside CAD/CAM Restorations

Solventum US LLC

Status: Completed

Conditions: Dental Cements; Caries,Dental

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04279574

EM-11-050060

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

CAD/CAM Onlays

Other group

Description:

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).

Treatment:

Device: Lithium disilicate onlays (IPS emaxCAD/Ivoclar)

CAD/CAM Crowns

Other group

Description:

Full contour zirconia crowns (3M Chairside Zirconia/3M) will be cemented using a self-adhesive cement (3M).

Treatment:

Device: Chairside zirconia crowns (3M)