Clinical Performance of Chairside CAD/CAM Restorations

NCT ID: NCT04279574

Last Updated: 2025-03-24

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-26

Study Completion Date

2024-05-22

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.

Conditions

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Dental Cements Caries,Dental

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type OTHER

Lithium disilicate onlays (IPS emaxCAD/Ivoclar)

Intervention Type DEVICE

Restoration of posterior teeth

CAD/CAM Crowns

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

Group Type OTHER

Chairside zirconia crowns (3M)

Intervention Type DEVICE

Restoration of posterior teeth

Interventions

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Lithium disilicate onlays (IPS emaxCAD/Ivoclar)

Restoration of posterior teeth

Intervention Type DEVICE

Chairside zirconia crowns (3M)

Restoration of posterior teeth

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role collaborator

3M

INDUSTRY

Sponsor Role collaborator

Solventum US LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paula Myhre

Role: STUDY_DIRECTOR

Solventum

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 20628774 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14158464 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14121956 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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EM-11-050060

Identifier Type: -

Identifier Source: org_study_id

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