Skip to main content
OpenTrials
Completed

NCT Number: NCT04279574

Clinical Performance of Chairside CAD/CAM Restorations

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dental Cements Caries,Dental Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109-1078, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lithium disilicate onlays (IPS emaxCAD/Ivoclar)

Device

Restoration of posterior teeth

Chairside zirconia crowns (3M)

Device

Restoration of posterior teeth

Primary outcomes

  1. Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Retention Scores]

    Time frame: 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 outcomes

  1. Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Material Fracture Scores]

    Time frame: 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.]

  2. Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Form - Mesial]

    Time frame: 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.]

  3. Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Point - Mesial Scores]

    Time frame: 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.]

  4. Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Form - Distal Scores]

    Time frame: 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.]

  5. Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Point - Distal Scores]

    Time frame: 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.]

  6. Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Occlusal Contour and Wear Scores]

    Time frame: 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.]

  7. Biologic Properties of Restorations (Onlays and Crowns) [Recurrence of Caries, Erosion, Abfraction Scores]

    Time frame: 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.]

  8. Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Marginal Adaptation Scores]

    Time frame: 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.]

  9. Esthetic Properties of Restorations (Onlays and Crowns) [Surface Luster Scores]

    Time frame: 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]

  10. Short-term Post-operative Sensitivity (Onlays and Crowns)

    Time frame: 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.

  11. Gingival Index (Onlays and Crowns)

    Time frame: 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]

  12. Plaque Index (Onlays and Crowns)

    Time frame: 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]

  13. Esthetic Properties Clinical Performance of Restorations (Onlays and Crowns) [Aesthetic Anatomical Form]

    Time frame: 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]

  14. Biologic Properties of Restorations (Onlays and Crowns) [Post-operative Sensitivity]

    Time frame: 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.]

  15. Esthetic Properties of Restorations (Onlays and Crowns) [Surface Staining Scores]

    Time frame: 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]

  16. Esthetic Properties of Restorations (Onlays and Crowns) [Margin Staining Scores]

    Time frame: 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]

  17. Esthetic Properties of Restorations (Onlays and Crowns) [Color Match and Translucency Scores]

    Time frame: 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]

  18. Esthetic Properties of Restorations (Onlays and Crowns) [Aesthetic Anatomical Form Scores]

    Time frame: 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]

Sponsors and collaborators

Lead sponsor

Solventum US LLC

Industry

Collaborators

  • 3M
  • University of Michigan

Registry information

Official study title

Clinical Performance of Chairside CAD/CAM Restorations Using a New Adhesive Cement

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Feb 21, 2020
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.