Clinical trial NCT04279574: Clinical Performance of Chairside CAD/CAM Restorations
Official title: Clinical Performance of Chairside CAD/CAM Restorations Using a New Adhesive Cement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Cements
Caries,Dental
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: University of Michigan
name: 3M
First posted: 2020-02-21
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

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

Primary outcomes:
measure: Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Retention Scores]
timeFrame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Secondary outcomes:
measure: Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Material Fracture Scores]
timeFrame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
measure: Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Form - Mesial]
timeFrame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
measure: Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Point - Mesial Scores]
timeFrame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
measure: Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Form - Distal Scores]
timeFrame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
measure: Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Point - Distal Scores]
timeFrame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
measure: Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Occlusal Contour and Wear Scores]
timeFrame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
measure: Biologic Properties of Restorations (Onlays and Crowns) [Recurrence of Caries, Erosion, Abfraction Scores]
timeFrame: 3 years with assessments at 6 months, 1 year, 2 years, and 3 years
measure: Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Marginal Adaptation Scores]
timeFrame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
measure: Esthetic Properties of Restorations (Onlays and Crowns) [Surface Luster Scores]
timeFrame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
measure: Short-term Post-operative Sensitivity (Onlays and Crowns)
timeFrame: up to 4 weeks after baseline with weekly assessments or until the restoration is reported asymptomatic
measure: Gingival Index (Onlays and Crowns)
timeFrame: 3 years with assessments at 6 months, 1 year, 2 years, and 3 years
measure: Plaque Index (Onlays and Crowns)
timeFrame: 3 years with assessments at 6 months, 1 year, 2 years, and 3 years
measure: Esthetic Properties Clinical Performance of Restorations (Onlays and Crowns) [Aesthetic Anatomical Form]
timeFrame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
measure: Biologic Properties of Restorations (Onlays and Crowns) [Post-operative Sensitivity]
timeFrame: 3 years with assessments at 6 months, 1 year, 2 years, and 3 years
measure: Esthetic Properties of Restorations (Onlays and Crowns) [Surface Staining Scores]
timeFrame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
measure: Esthetic Properties of Restorations (Onlays and Crowns) [Margin Staining Scores]
timeFrame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
measure: Esthetic Properties of Restorations (Onlays and Crowns) [Color Match and Translucency Scores]
timeFrame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
measure: Esthetic Properties of Restorations (Onlays and Crowns) [Aesthetic Anatomical Form Scores]
timeFrame: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: Solventum
name: Paula Myhre
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.