N/A N=68 Treatment

Clinical Performance of Chairside CAD/CAM Restorations

Dental Cements · Caries,Dental

Bottom Line

View on ClinicalTrials.gov: NCT04279574 ↗

Enrolled (actual)

Serious AEs

1.5%

Results posted

Mar 2025

Primary outcome: Primary: Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Retention Scores] — 40; 40; 0; 0 Restorations

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Lithium disilicate onlays (IPS emaxCAD/Ivoclar) (Device); Chairside zirconia crowns (3M) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Solventum US LLC
Primary completion: May 2024

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	—

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.

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

View full record on ClinicalTrials.gov →

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.