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Clinical Performance of Ceramic CAD/CAM Crowns

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ClinicalTrials.gov Identifier: NCT03921307
Recruitment Status : Completed
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed Alamri, University of Toronto

Brief 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.

Condition or disease
Tooth Crown Fracture Dental Caries

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 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.

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Study Type : Observational
Actual Enrollment : 251 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical Performance of Monolithic Lithium-disilicate Glass-Ceramic CAD/CAM Crowns
Actual Study Start Date : May 15, 2017
Actual Primary Completion Date : December 21, 2018
Actual Study Completion Date : December 21, 2018



Primary Outcome Measures :
  1. Survival percentage [ Time Frame: 6 years ]
    Kaplan Meier analysis of survival of the crowns

  2. Clinical performance of crowns via modified California Dental Association (CDA) criteria [ Time Frame: 6 years ]
    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.


Secondary Outcome Measures :
  1. Patient satisfaction with esthetic and function of crowns [ Time Frame: 6 years ]
    Using Visual Analog Scale (VAS)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All patients who received dental treatment at the Faculty of Dentistry, University of Toronto.
Criteria

Inclusion Criteria:

  • Healthy periodontal tissue Adequate root canal treatment

Exclusion Criteria:

  • Parafunctional habits

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921307


Locations
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Canada, Ontario
University of Toronto
Toronto, Ontario, Canada, M5G 1G6
Sponsors and Collaborators
University of Toronto
Investigators
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Principal Investigator: Ahmed Alamri University of Toronto

Publications:

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Responsible Party: Ahmed Alamri, Assistant Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT03921307     History of Changes
Other Study ID Numbers: 33291
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmed Alamri, University of Toronto:
Computer-Aided Design
dental crowns
survival
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases