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Clinical Performance of All-ceramic Posterior Crowns. A Randomized, Prospective Clinical.

Primary Purpose

Dental Prosthesis Failure

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
IPS e.max CAD, Ivoclar Vivadent
BruxZir, Glidewell
BruxZir*, Glidewell
Sponsored by
Malmö University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Prosthesis Failure focused on measuring all ceramic, zirconia, crown, clinal trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  • need of one or more dental crowns in the posterior dentition, premolars and molars

Exclusion criteria:

  • high caries activity/risk for caries and/or advanced periodontal disease

Sites / Locations

  • Malmö University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Glass-ceramic

Zirconia

Zirconia with mini-veneer

Arm Description

30 dental crowns of lithium-disilicate glass-ceramic

30 dental crowns of high translucent zirconia

30 dental crowns of high translucent zirconia with a mini-veneer of porcelain

Outcomes

Primary Outcome Measures

Clinical perfomance
To identify if there are any differences between the materials. The marginal integrity and surface will be rated as excellent, acceptable, retrievable or not acceptable according to a modified California Dental Association (CDA) quality assessment system.
Clinical perfomance
To identify if there are any differences between the materials. The marginal integrity and surface will be rated as excellent, acceptable, retrievable or not acceptable according to a modified California Dental Association (CDA) quality assessment system.
Clinical perfomance
To identify if there are any differences between the materials. The marginal integrity and surface will be rated as excellent, acceptable, retrievable or not acceptable according to a modified California Dental Association (CDA) quality assessment system.
Clinical perfomance
To identify if there are any differences between the materials. The marginal integrity and surface will be rated as excellent, acceptable, retrievable or not acceptable according to a modified California Dental Association (CDA) quality assessment system.

Secondary Outcome Measures

Patient questionnaire
Self-reported satisfaction with their treatment from 0 ('not satisfied at all') to 10 ('completely satisfied').
Patient questionnaire
Self-reported satisfaction with their treatment from 0 ('not satisfied at all') to 10 ('completely satisfied').
Patient questionnaire
Self-reported satisfaction with their treatment from 0 ('not satisfied at all') to 10 ('completely satisfied').
Patient questionnaire
Self-reported satisfaction with their treatment from 0 ('not satisfied at all') to 10 ('completely satisfied').

Full Information

First Posted
February 11, 2020
Last Updated
September 6, 2021
Sponsor
Malmö University
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1. Study Identification

Unique Protocol Identification Number
NCT04272112
Brief Title
Clinical Performance of All-ceramic Posterior Crowns. A Randomized, Prospective Clinical.
Official Title
Clinical Performance of All-ceramic Posterior Crowns. A Randomized, Prospective Clinical Trial Comparing Glass-ceramic Crowns to Monolithic Translucent Zirconia Crowns With and Without a Semi-veneer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Malmö University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a randomized, prospective clinical trial. The aim of the project is to assess the clinical performance of three types of tooth-supported crowns; monolithic high translucent colored zirconia, crowns of high-translucent colored zirconia with a mini-veneer buccally and crowns of lithium-disilicate glass-ceramic. Crowns will be placed on posterior teeth and evaluated from an esthetic and functional point of view, to identify if there are any differences between the materials.
Detailed Description
90 monolithic tooth-supported crowns are planned to be included in the study; 30 crowns of high translucent zirconia (BruxZir, Glidewell), 30 crowns of high translucent zirconia (BruxZir, Glidewell) with a mini-veneer of porcelain and 30 crowns of lithium-disilicate glass-ceramic (IPS e.max CAD, Ivoclar Vivadent AG, Schaan, Liechtenstein). Patients with indications for single crowns will be recruited from three general dental clinics. Inclusion criteria for participating in this study are patients in need of crowns in the posterior dentition, premolars and molars. Exclusion criteria are patients with high caries activity/risk for caries and/or advanced periodontal disease. Patients who meet the criteria will be offered the opportunity to participate in the study. They will receive written information about the study design, clinical procedures and the materials and methods to be used. Patients who are interested will confirm their participation by a written consent. The patients will be offered an extended warranty for the crowns in case of failure. The study has been approved by the Regional Ethical Board in Lund, Sweden

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Prosthesis Failure
Keywords
all ceramic, zirconia, crown, clinal trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glass-ceramic
Arm Type
Active Comparator
Arm Description
30 dental crowns of lithium-disilicate glass-ceramic
Arm Title
Zirconia
Arm Type
Active Comparator
Arm Description
30 dental crowns of high translucent zirconia
Arm Title
Zirconia with mini-veneer
Arm Type
Active Comparator
Arm Description
30 dental crowns of high translucent zirconia with a mini-veneer of porcelain
Intervention Type
Combination Product
Intervention Name(s)
IPS e.max CAD, Ivoclar Vivadent
Intervention Description
Type: monolithic lithium-disilicate glass ceramic
Intervention Type
Combination Product
Intervention Name(s)
BruxZir, Glidewell
Intervention Description
Type: high translucent zirconia
Intervention Type
Combination Product
Intervention Name(s)
BruxZir*, Glidewell
Intervention Description
Type: high translucent zirconia with a mini-veneer of porcelain
Primary Outcome Measure Information:
Title
Clinical perfomance
Description
To identify if there are any differences between the materials. The marginal integrity and surface will be rated as excellent, acceptable, retrievable or not acceptable according to a modified California Dental Association (CDA) quality assessment system.
Time Frame
12 month
Title
Clinical perfomance
Description
To identify if there are any differences between the materials. The marginal integrity and surface will be rated as excellent, acceptable, retrievable or not acceptable according to a modified California Dental Association (CDA) quality assessment system.
Time Frame
24 month
Title
Clinical perfomance
Description
To identify if there are any differences between the materials. The marginal integrity and surface will be rated as excellent, acceptable, retrievable or not acceptable according to a modified California Dental Association (CDA) quality assessment system.
Time Frame
36 month
Title
Clinical perfomance
Description
To identify if there are any differences between the materials. The marginal integrity and surface will be rated as excellent, acceptable, retrievable or not acceptable according to a modified California Dental Association (CDA) quality assessment system.
Time Frame
60 month
Secondary Outcome Measure Information:
Title
Patient questionnaire
Description
Self-reported satisfaction with their treatment from 0 ('not satisfied at all') to 10 ('completely satisfied').
Time Frame
12 month
Title
Patient questionnaire
Description
Self-reported satisfaction with their treatment from 0 ('not satisfied at all') to 10 ('completely satisfied').
Time Frame
24 month
Title
Patient questionnaire
Description
Self-reported satisfaction with their treatment from 0 ('not satisfied at all') to 10 ('completely satisfied').
Time Frame
36 month
Title
Patient questionnaire
Description
Self-reported satisfaction with their treatment from 0 ('not satisfied at all') to 10 ('completely satisfied').
Time Frame
60 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: need of one or more dental crowns in the posterior dentition, premolars and molars Exclusion criteria: high caries activity/risk for caries and/or advanced periodontal disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christel Larsson, PhD
Organizational Affiliation
Malmö University
Official's Role
Study Chair
Facility Information:
Facility Name
Malmö University
City
Malmö
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
25580846
Citation
Le M, Papia E, Larsson C. The clinical success of tooth- and implant-supported zirconia-based fixed dental prostheses. A systematic review. J Oral Rehabil. 2015 Jun;42(6):467-80. doi: 10.1111/joor.12272. Epub 2015 Jan 10.
Results Reference
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PubMed Identifier
31105161
Citation
LE M, Larsson C, Papia E. Bond strength between MDP-based cement and translucent zirconia. Dent Mater J. 2019 Jun 1;38(3):480-489. doi: 10.4012/dmj.2018-194. Epub 2019 May 17.
Results Reference
background
PubMed Identifier
24392475
Citation
Larsson C, Wennerberg A. The clinical success of zirconia-based crowns: a systematic review. Int J Prosthodont. 2014 Jan-Feb;27(1):33-43. doi: 10.11607/ijp.3647.
Results Reference
background
PubMed Identifier
23865549
Citation
Johansson C, Kmet G, Rivera J, Larsson C, Vult Von Steyern P. Fracture strength of monolithic all-ceramic crowns made of high translucent yttrium oxide-stabilized zirconium dioxide compared to porcelain-veneered crowns and lithium disilicate crowns. Acta Odontol Scand. 2014 Feb;72(2):145-53. doi: 10.3109/00016357.2013.822098. Epub 2013 Jul 18.
Results Reference
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Clinical Performance of All-ceramic Posterior Crowns. A Randomized, Prospective Clinical.

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