NCT03921307

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
251

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 19, 2019

Completed
Last Updated

April 19, 2019

Status Verified

April 1, 2019

Enrollment Period

1.6 years

First QC Date

April 7, 2019

Last Update Submit

April 16, 2019

Conditions

Keywords

Computer-Aided Designdental crownssurvival

Outcome Measures

Primary Outcomes (2)

  • Survival percentage

    Kaplan Meier analysis of survival of the crowns

    6 years

  • 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 Outcomes (1)

  • Patient satisfaction with esthetic and function of crowns

    6 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Healthy periodontal tissue Adequate root canal treatment

You may not qualify if:

  • Parafunctional habits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toronto

Toronto, Ontario, M5G 1G6, Canada

Location

Related 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.

    PMID: 24757702BACKGROUND
  • 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.

    PMID: 26428908BACKGROUND
  • 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.

    PMID: 22282749BACKGROUND
  • 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.

    PMID: 20516109BACKGROUND
  • 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.

    PMID: 29103104BACKGROUND
  • 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.

    PMID: 20552085BACKGROUND
  • 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.

    PMID: 25935085BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Ahmed Alamri

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 7, 2019

First Posted

April 19, 2019

Study Start

May 15, 2017

Primary Completion

December 21, 2018

Study Completion

December 21, 2018

Last Updated

April 19, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations