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.

Study Overview

• Status: Active, not recruiting
• Conditions: Caries,Dental; Dental Cements
• Intervention / Treatment: Device: Lithium disilicate onlays (IPS emaxCAD/Ivoclar); Device: Chairside zirconia crowns (3M)

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-1078
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: CAD/CAM Onlays; 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); Restoration of posterior teeth
Other: CAD/CAM Crowns; Full contour zirconia crowns (3M Chairside Zirconia/3M) will be cemented using a self-adhesive cement (3M).	Device: Chairside zirconia crowns (3M); Restoration of posterior teeth

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: 3M
• Collaborators: University of Michigan
• Investigators: Study Director: Bernadette Rauch, 3M

Publications and helpful links

General Publications

• SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.
• LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.
• Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2020
• Primary Completion (Anticipated): August 30, 2024
• Study Completion (Anticipated): October 30, 2024

Study Registration Dates

• First Submitted: February 13, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Antimanic Agents; Lithium Carbonate
• Other Study ID Numbers: CR19_03 050044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No