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

NCT ID: NCT04272112

Last Updated: 2021-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2021-09-01

Brief Summary

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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

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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

Conditions

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Dental Prosthesis Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Glass-ceramic

30 dental crowns of lithium-disilicate glass-ceramic

Group Type ACTIVE_COMPARATOR

BruxZir, Glidewell

Intervention Type COMBINATION_PRODUCT

Type: high translucent zirconia

BruxZir*, Glidewell

Intervention Type COMBINATION_PRODUCT

Type: high translucent zirconia with a mini-veneer of porcelain

Zirconia

30 dental crowns of high translucent zirconia

Group Type ACTIVE_COMPARATOR

IPS e.max CAD, Ivoclar Vivadent

Intervention Type COMBINATION_PRODUCT

Type: monolithic lithium-disilicate glass ceramic

BruxZir*, Glidewell

Intervention Type COMBINATION_PRODUCT

Type: high translucent zirconia with a mini-veneer of porcelain

Zirconia with mini-veneer

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

Group Type ACTIVE_COMPARATOR

IPS e.max CAD, Ivoclar Vivadent

Intervention Type COMBINATION_PRODUCT

Type: monolithic lithium-disilicate glass ceramic

BruxZir, Glidewell

Intervention Type COMBINATION_PRODUCT

Type: high translucent zirconia

Interventions

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IPS e.max CAD, Ivoclar Vivadent

Type: monolithic lithium-disilicate glass ceramic

Intervention Type COMBINATION_PRODUCT

BruxZir, Glidewell

Type: high translucent zirconia

Intervention Type COMBINATION_PRODUCT

BruxZir*, Glidewell

Type: high translucent zirconia with a mini-veneer of porcelain

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Malmö University

OTHER

Sponsor Role lead

Responsible Party

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Minh Le

Prinicipal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christel Larsson, PhD

Role: STUDY_CHAIR

Malmö University

Locations

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Malmö University

Malmo, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 25580846 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31105161 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24392475 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23865549 (View on PubMed)

Other Identifiers

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NN1401

Identifier Type: -

Identifier Source: org_study_id

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