Y-TZP and In-mouth Low Thermal Degradation: A Prospective Clinical Study
Low Thermal Degradation of Monolithic Zirconia Prostheses: an up to 5-year Original Prospective Clinical Study Using ex Vivo Analyses
1 other identifier
interventional
101
1 country
1
Brief Summary
The objective of this work is to study in-mouth aging and LTD of monolithic zirconia restorations. Microstructural changes characteristic of LTD processes, wear, and clinical behaviour following standard parameters will be evaluated. Notably Raman spectroscopy and 3D laser surface analysis will be used, directly on the restorations, which will be removed at regular intervals.The working hypothesis is that LTD process is very slow at the scale at the lifespan of dental prostheses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 26, 2014
CompletedFirst Posted
Study publicly available on registry
May 29, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedAugust 7, 2019
August 1, 2019
2.2 years
May 26, 2014
August 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
in-mouth LTD of monolithic zirconia restorations on natural teeth and implants
up to 5 years
Study Arms (1)
Experimental: Zirconia monolithic crowns and bridges
EXPERIMENTALEvaluation of Lava Plus zirconia dental crowns and bridges
Interventions
Zirconia monolithic dental crowns and bridges evaluation
Eligibility Criteria
You may qualify if:
- Full zirconia crowns in the posterior region (molar/premolar)
- On teeth or implants
- Single unit restorations cemented on natural teeth and implants (including screw-retained restorations if possible, but no internal connections)
- Multi-unit restorations on implants
- If nightguard: to be performed on the antagonist
You may not qualify if:
- Patients with removable prosthesis as an antagonist
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Liegelead
- DMG Paris Descartescollaborator
Study Sites (1)
Institute of Dentistry University of Liege
Liège, 4000, Belgium
Related Publications (2)
Koenig V, Douillard T, Chevalier J, Amiard F, Lamy de la Chapelle M, Le Goff S, Vanheusden A, Dardenne N, Wulfman C, Mainjot A. Intraoral low-temperature degradation of monolithic zirconia dental prostheses: 5-year results of a prospective clinical study with ex vivo monitoring. Dent Mater. 2024 Feb;40(2):198-209. doi: 10.1016/j.dental.2023.11.008. Epub 2023 Nov 10.
PMID: 37951752DERIVEDKoenig V, Wulfman CP, Derbanne MA, Dupont NM, Le Goff SO, Tang ML, Seidel L, Dewael TY, Vanheusden AJ, Mainjot AK. Aging of monolithic zirconia dental prostheses: Protocol for a 5-year prospective clinical study using ex vivo analyses. Contemp Clin Trials Commun. 2016 Jun 17;4:25-32. doi: 10.1016/j.conctc.2016.06.001. eCollection 2016 Dec 15.
PMID: 29736467DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
May 26, 2014
First Posted
May 29, 2014
Study Start
February 1, 2014
Primary Completion
April 1, 2016
Study Completion
April 1, 2021
Last Updated
August 7, 2019
Record last verified: 2019-08