Clinical Performance of Chairside CAD/CAM Restorations

Caries,Dental Clinical Trial

Official title:

Clinical Performance of Chairside CAD/CAM Restorations

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04279574
• Other study ID #: CR19_03 050044
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 26, 2020
• Est. completion date: October 30, 2024

Study information

• Verified date: April 2023
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. completion date: October 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Caries,Dental
• Dental Caries
• Dental Cements

Intervention

Device:
• Lithium disilicate onlays (IPS emaxCAD/Ivoclar)
Restoration of posterior teeth
• Chairside zirconia crowns (3M)
Restoration of posterior teeth

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
3M	University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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