Study Results
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View full resultsBasic Information
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COMPLETED
NA
58 participants
INTERVENTIONAL
2020-08-26
2024-05-22
Brief Summary
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Full contour zirconia crowns will be cemented using a self-adhesive resin cement.
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Detailed Description
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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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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
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).
Lithium disilicate onlays (IPS emaxCAD/Ivoclar)
Restoration of posterior teeth
CAD/CAM Crowns
Full contour zirconia crowns (3M Chairside Zirconia/3M) will be cemented using a self-adhesive cement (3M).
Chairside zirconia crowns (3M)
Restoration of posterior teeth
Interventions
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Lithium disilicate onlays (IPS emaxCAD/Ivoclar)
Restoration of posterior teeth
Chairside zirconia crowns (3M)
Restoration of posterior teeth
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
89 Years
ALL
No
Sponsors
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University of Michigan
OTHER
3M
INDUSTRY
Solventum US LLC
INDUSTRY
Responsible Party
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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
Countries
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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EM-11-050060
Identifier Type: -
Identifier Source: org_study_id
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