Zirconia Monolithic Dental Restorations: In-mouth Behaviour, LTD and WearNCT02150226
Y-TZP and In-mouth Low Thermal Degradation: A Prospective Clinical Study
A study testing Lava plus (3M) crowns and bridges in people with Zirconia Monolithic Dental Restorations: In-mouth Behaviour, LTD and Wear, run by University of Liege at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Zirconia Monolithic Dental Restorations: In-mouth Behaviour, LTD and Wear
- What is being tested?
- Lava plus (3M) crowns and bridges
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2014to Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with removable prosthesis as an antagonist
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Thermal Degradation of Monolithic Zirconia Prostheses: an up to 5-year Original Prospective Clinical Study Using ex Vivo Analyses
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.
- Being tested
- Lava plus (3M) crowns and bridges
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lava plus (3M) crowns and bridgesDevice
Zirconia monolithic dental crowns and bridges evaluation
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Zirconia monolithic crowns and bridges | Experimental | Evaluation of Lava Plus zirconia dental crowns and bridges Receives: Device: Lava plus (3M) crowns and bridges |
What is being measured
The primary outcome is the main question the study is designed to answer.
in-mouth LTD of monolithic zirconia restorations on natural teeth and implants
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startFeb 2014
- Primary completionApr 2016
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Zirconia Monolithic Dental Restorations: In-mouth Behaviour, LTD and WearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Collaborators
- DMG Paris Descartes
- Responsible party
- Principal investigator, Mainjot Amélie, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150226
- Sponsor's protocol ID
- FZ001
- Status last verified
- Aug 2019
- First submitted
- 26 May 2014
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37951752Koenig 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.
PubMed 29736467
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Thermal Degradation of Monolithic Zirconia Prostheses: an up to 5-year Original Prospective Clinical Study Using ex Vivo Analyses
- ClinicalTrials.gov ID
- NCT02150226
- Acronym / sponsor ID
- FZ001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Collaborators
- DMG Paris Descartes
- Study start
- Feb 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2021 (estimated)
- First posted
- 29 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Zirconia monolithic crowns and bridges | Experimental | Device: Lava plus (3M) crowns and bridgesEvaluation of Lava Plus zirconia dental crowns and bridges |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with removable prosthesis as an antagonist
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lava plus (3M) crowns and bridgesZirconia monolithic dental crowns and bridges evaluation | Device | Experimental: Zirconia monolithic crowns and bridges |
Primary outcome
in-mouth LTD of monolithic zirconia restorations on natural teeth and implants
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Derived from this study: PubMed 37951752Koenig 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.
- Derived from this study: PubMed 29736467Koenig 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lava plus (3M) crowns and bridges in people with Zirconia Monolithic Dental Restorations: In-mouth Behaviour, LTD and Wear, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
in-mouth LTD of monolithic zirconia restorations on natural teeth and implants (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02150226, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.