- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03921307
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
Conditions
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.
Sponsor
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
- 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.
- Belli R, Petschelt A, Hofner B, Hajto 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.
- 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.
- 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. doi: 10.14219/jada.archive.2010.0355.
- 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.
- 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.
- 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.
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
Keywords
Additional Relevant MeSH Terms
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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