Clinical Performance of Ceramic CAD/CAM Crowns

Dental Caries Clinical Trial

Official title:

Clinical Performance of Monolithic Lithium-disilicate Glass-Ceramic CAD/CAM Crowns

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03921307
• Other study ID #: 33291
• Status: Completed
• Start date: May 15, 2017
• Est. completion date: December 21, 2018

Study information

• Verified date: April 2019
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study was to evaluate the clinical performance of laboratory and chairside fabricated monolithic anterior and posterior LDGC CAD/CAM crowns performed by predoctoral students at the University of Toronto and the effect of different patient and provider-related factors on their longevity and to compare them to the metal-ceramic (MC) crowns. A sample of LDGC CAD/CAM crowns (IPS e.max, Ivoclar Vivadent) provided by predoctoral students was evaluated. Crown preparations were made according to the specific criteria and were milled in-house using the CEREC bluecam and Omnicam systems. Crowns were cemented with Rely-X Unicem (3M/ESPE) and Calibra Universal (Dentsply Sirona) resin cements. Clinical assessment of the crowns and supporting periodontal structures was performed following the modified California Dental Association (CDA) criteria. Intra-oral photographs, periapical and bitewing radiographs were taken for further assessment by two evaluators. Two-hundred and fifty-one patients with 275 crowns were examined with a follow-up period of up to 6 years.

Description:

The clinical success of the monolithic Lithium-disilicate Glass-ceramic (LDGC) crowns manufactured with computer-aided design (CAD) / computer-aided manufacturing (CAM) technology provided by predoctoral students was not investigated. Thus, the purpose of this study was to evaluate the clinical performance of laboratory and chairside fabricated monolithic anterior and posterior LDGC CAD/CAM crowns performed by predoctoral students at the University of Toronto and the effect of different patient and provider-related factors on their longevity and to compare them to the metal-ceramic (MC) crowns. A sample of LDGC CAD/CAM crowns (IPS e.max, Ivoclar Vivadent) provided by predoctoral students was evaluated. Crown preparations were made according to the specific criteria and were milled in-house using the CEREC bluecam and Omnicam systems. Crowns were cemented with Rely-X Unicem (3M/ESPE) and Calibra Universal (Dentsply Sirona) resin cements. Clinical assessment of the crowns and supporting periodontal structures was performed following the modified California Dental Association (CDA) criteria. Intra-oral photographs, periapical and bitewing radiographs were taken for further assessment by two evaluators. Two-hundred and fifty-one patients with 275 crowns were examined with a follow-up period of up to 6 years. Part 1 evaluated the performance of laboratory-fabricated LDGC CAD/CAM crowns. Part 2 evaluated the performance of chairside LDGC CAD/CAM crowns. Forty crowns were evaluated. Part 3 evaluated the performance of LDGC CAD/CAM and MC crowns using split-mouth design. A total of 25 patients and 50 crowns (25 crowns for each group) were examined.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: December 21, 2018
• Est. primary completion date: December 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy periodontal tissue Adequate root canal treatment

Exclusion Criteria:

• Parafunctional habits

Related Conditions & MeSH terms

• Dental Caries
• Tooth Crown Fracture

Locations

Country	Name	City	State
Canada	University of Toronto	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (7)

Altamimi AM, Tripodakis AP, Eliades G, Hirayama H. Comparison of fracture resistance and fracture characterization of bilayered zirconia/fluorapatite and monolithic lithium disilicate all ceramic crowns. Int J Esthet Dent. 2014 Spring;9(1):98-110. — View Citation

Belli R, Petschelt A, Hofner B, Hajtó J, Scherrer SS, Lohbauer U. Fracture Rates and Lifetime Estimations of CAD/CAM All-ceramic Restorations. J Dent Res. 2016 Jan;95(1):67-73. doi: 10.1177/0022034515608187. Epub 2015 Oct 1. — View Citation

Cortellini D, Canale A. Bonding lithium disilicate ceramic to feather-edge tooth preparations: a minimally invasive treatment concept. J Adhes Dent. 2012 Feb;14(1):7-10. doi: 10.3290/j.jad.a22708. — View Citation

Fasbinder DJ, Dennison JB, Heys D, Neiva G. A clinical evaluation of chairside lithium disilicate CAD/CAM crowns: a two-year report. J Am Dent Assoc. 2010 Jun;141 Suppl 2:10S-4S. — View Citation

Rauch A, Reich S, Dalchau L, Schierz O. Clinical survival of chair-side generated monolithic lithium disilicate crowns:10-year results. Clin Oral Investig. 2018 May;22(4):1763-1769. doi: 10.1007/s00784-017-2271-3. Epub 2017 Nov 4. — View Citation

Reich S, Fischer S, Sobotta B, Klapper HU, Gozdowski S. A preliminary study on the short-term efficacy of chairside computer-aided design/computer-assisted manufacturing- generated posterior lithium disilicate crowns. Int J Prosthodont. 2010 May-Jun;23(3):214-6. — View Citation

Seydler B, Schmitter M. Clinical performance of two different CAD/CAM-fabricated ceramic crowns: 2-Year results. J Prosthet Dent. 2015 Aug;114(2):212-6. doi: 10.1016/j.prosdent.2015.02.016. Epub 2015 Apr 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival percentage	Kaplan Meier analysis of survival of the crowns	6 years
Primary	Clinical performance of crowns via modified California Dental Association (CDA) criteria	Biological complications: pulpal involvement, recurrent caries, tooth fracture. Technical complications: marginal integrity (slight marginal discrepancy, open margins, marginal overhang, under-contoured margins), loss of retention, crown fracture, chipping/crack lines, open proximal contact. Esthetic complications: surface texture/smoothness, color match/mismatch, marginal discoloration, over or under-contoured.	6 years
Secondary	Patient satisfaction with esthetic and function of crowns	Using Visual Analog Scale (VAS)	6 years