Viewing Study NCT03921307



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Last Modification Date: 2024-10-26 @ 1:08 PM
Study NCT ID: NCT03921307
Status: COMPLETED
Last Update Posted: 2019-04-19
First Post: 2019-04-07

Brief Title: Clinical Performance of Ceramic CADCAM Crowns
Sponsor: University of Toronto
Organization: University of Toronto

Study Overview

Official Title: Clinical Performance of Monolithic Lithium-disilicate Glass-Ceramic CADCAM Crowns
Status: COMPLETED
Status Verified Date: 2019-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study was to evaluate the clinical performance of laboratory and chairside fabricated monolithic anterior and posterior LDGC CADCAM 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 CADCAM crowns IPS emax 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 3MESPE 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
Detailed 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 CADCAM 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 CADCAM crowns IPS emax 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 3MESPE 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 CADCAM crowns Part 2 evaluated the performance of chairside LDGC CADCAM crowns Forty crowns were evaluated Part 3 evaluated the performance of LDGC CADCAM and MC crowns using split-mouth design A total of 25 patients and 50 crowns 25 crowns for each group were examined

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None