Clinical Performance of Ceramic CAD/CAM Crowns

April 16, 2019 updated by: Ahmed Alamri, University of Toronto

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

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.

Study Overview

Status

Completed

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.

Study Type

Observational

Enrollment (Actual)

251

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5G 1G6
        • University of Toronto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients who received dental treatment at the Faculty of Dentistry, University of Toronto.

Description

Inclusion Criteria:

  • Healthy periodontal tissue Adequate root canal treatment

Exclusion Criteria:

  • Parafunctional habits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival percentage
Time Frame: 6 years
Kaplan Meier analysis of survival of the crowns
6 years
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.
6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction with esthetic and function of crowns
Time Frame: 6 years
Using Visual Analog Scale (VAS)
6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ahmed Alamri, University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 15, 2017

Primary Completion (ACTUAL)

December 21, 2018

Study Completion (ACTUAL)

December 21, 2018

Study Registration Dates

First Submitted

April 7, 2019

First Submitted That Met QC Criteria

April 16, 2019

First Posted (ACTUAL)

April 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 33291

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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