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

Dental Prosthesis Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04272112
• Other study ID #: NN1401
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: September 1, 2021

Study information

• Verified date: September 2021
• Source: Malmö University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 1, 2021
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Prosthesis Failure
• Prosthesis Failure

Intervention

Combination Product:
• IPS e.max CAD, Ivoclar Vivadent
Type: monolithic lithium-disilicate glass ceramic
• BruxZir, Glidewell
Type: high translucent zirconia
• BruxZir*, Glidewell
Type: high translucent zirconia with a mini-veneer of porcelain

Locations

Country	Name	City	State
Sweden	Malmö University	Malmö

Sponsors (1)

Lead Sponsor	Collaborator
Malmö University

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

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. — View 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. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 month
Primary	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.	24 month
Primary	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.	36 month
Primary	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.	60 month
Secondary	Patient questionnaire	Self-reported satisfaction with their treatment from 0 ('not satisfied at all') to 10 ('completely satisfied').	12 month
Secondary	Patient questionnaire	Self-reported satisfaction with their treatment from 0 ('not satisfied at all') to 10 ('completely satisfied').	24 month
Secondary	Patient questionnaire	Self-reported satisfaction with their treatment from 0 ('not satisfied at all') to 10 ('completely satisfied').	36 month
Secondary	Patient questionnaire	Self-reported satisfaction with their treatment from 0 ('not satisfied at all') to 10 ('completely satisfied').	60 month