Tooth WearNCT02828696
Minimally Invasive Treatment of Worn Dentition With Innovative CAD-CAM Composites
A study testing "No prep" treatment of worn dentition with CAD-CAM composite in people with Tooth Wear, run by University of Liege at 1 site in Belgium.
Trial summary
This study evaluates the effectiveness of a minimally invasive treatment, consisting of partial polymer-infiltrated-ceramic-network (PICN) restorations, used in case of rehabilitation of advanced and generalized dental wear over a period of 5 years. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Wear
- What is being tested?
- "No prep" treatment of worn dentition with CAD-CAM composite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2016to Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients presenting advanced and generalized worn dentition
- All the posterior teeth (minus 2) present wear
- All the anterior teeth (tooth n°13 to n°23) need palatal veneers
Who cannot join
- More than one missing tooth on each mandible
- Patients with crown(s), bridge(s) or implant(s)
- Patients with non-stabilized parodontite
- Smoker
- Patients suffering from :
- Parkinson's Disease
Show all 9Show fewer
- Severe osteoarthritis
- Spontaneous pain in the temporomandibular joints, shift of the mandible and an opening limit (25 mm)
- Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability
Trial locations and contacts
1 site in 1 country.
Amélie K Mainjot contact
Julie Oudkerk contact
Belgium1 site, 1 recruiting
- Recruiting
Institute of Dentistry University of Liege
Liège, 4000
Amélie K Mainjot, a.mainjot@chu.ulg.ac.be
Julie Oudkerk
About this study
This study evaluates the effectiveness of a minimally invasive treatment, consisting of partial polymer-infiltrated-ceramic-network (PICN) restorations, used in case of rehabilitation of advanced and generalized dental wear over a period of 5 years.
- Conditions
- Tooth Wear
- Being tested
- "No prep" treatment of worn dentition with CAD-CAM composite
- Keywords
- CAD-CAM composites, Worn dentition, minimally invasive treatment
- Medical subject headings
- Tooth Wear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"No prep" treatment of worn dentition with CAD-CAM compositeDevice
Realization of minimally invasive prostheses in PICN (CAD-CAM composite)for worn dentition. Tooth tissues are preserved: no preparation is performed and ultra-thin restorations are CAD-CAM milled.
| Study group | Role | What they receive |
|---|---|---|
| No prep | Other | "No prep" treatment of worn dentition with CAD-CAM composite (PICN) Receives: Device: "No prep" treatment of worn dentition with CAD-CAM composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation of minimally-invasive treatment protocol of worn dentition
Clinical evaluation following FDI criteria
Measured: 5 years
Quality of life evaluation of minimally-invasive treatment protocol of worn dentition
Quality of life questionnaires
Measured: 5 years
Secondary outcomes (2)
Toxicology evaluation of PICN restorations mechanical and biological behaviour
Toxicology ex vivo evaluation
Measured: 5 years
Wear evaluation of PICN restorations mechanical and biological behaviour
Wear ex vivo evaluation
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tooth 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
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mainjot Amélie, University of Liege
- Investigators
- Amélie Mainjot, Study director, University Hospital Center (CHU) of Liège
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828696
- Sponsor's protocol ID
- NP001
- Status last verified
- May 2019
- First submitted
- 15 Jun 2016
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Oudkerk J, Herman R, Eldafrawy M, Wulfman C, Ernst M, Vanheusden A, Mainjot A. Intraoral wear of PICN CAD-CAM composite restorations used in severe tooth wear treatment: 5-year results of a prospective clinical study using 3D profilometry. Dent Mater. 2024 Jul;40(7):1056-1063. doi: 10.1016/j.dental.2024.05.015. Epub 2024 May 18.
PubMed 38762399
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Treatment of Worn Dentition With Innovative CAD-CAM Composites
- ClinicalTrials.gov ID
- NCT02828696
- Acronym / sponsor ID
- NP001
- Conditions
- Tooth Wear
- Keywords
- CAD-CAM composites, Worn dentition, minimally invasive treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 12 Jul 2016 (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.
This study evaluates the effectiveness of a minimally invasive treatment, consisting of partial polymer-infiltrated-ceramic-network (PICN) restorations, used in case of rehabilitation of advanced and generalized dental wear over a period of 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No prep | Other | Device: "No prep" treatment of worn dentition with CAD-CAM composite"No prep" treatment of worn dentition with CAD-CAM composite (PICN) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients presenting advanced and generalized worn dentition
- All the posterior teeth (minus 2) present wear
- All the anterior teeth (tooth n°13 to n°23) need palatal veneers
Key exclusion criteria (9 listed)
- More than one missing tooth on each mandible
- Patients with crown(s), bridge(s) or implant(s)
- Patients with non-stabilized parodontite
- Smoker
- Patients suffering from :
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 |
|---|---|---|
| "No prep" treatment of worn dentition with CAD-CAM compositeRealization of minimally invasive prostheses in PICN (CAD-CAM composite)for worn dentition. Tooth tissues are preserved: no preparation is performed and ultra-thin restorations are CAD-CAM milled. | Device | No prep |
Primary outcome
Clinical evaluation of minimally-invasive treatment protocol of worn dentition
Time frame: 5 years
Clinical evaluation following FDI criteria
Quality of life evaluation of minimally-invasive treatment protocol of worn dentition
Time frame: 5 years
Quality of life questionnaires
2 secondary outcomes
Toxicology evaluation of PICN restorations mechanical and biological behaviour
Time frame: 5 years
Wear evaluation of PICN restorations mechanical and biological behaviour
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- Derived from this study: PubMed 38762399Oudkerk J, Herman R, Eldafrawy M, Wulfman C, Ernst M, Vanheusden A, Mainjot A. Intraoral wear of PICN CAD-CAM composite restorations used in severe tooth wear treatment: 5-year results of a prospective clinical study using 3D profilometry. Dent Mater. 2024 Jul;40(7):1056-1063. doi: 10.1016/j.dental.2024.05.015. Epub 2024 May 18.
- Individual participant dataSharing planned: Undecided
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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.
Amélie K Mainjot contact
Julie Oudkerk contact
Amélie Mainjot study director
University Hospital Center (CHU) of Liège
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "No prep" treatment of worn dentition with CAD-CAM composite in people with Tooth 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 3 inclusion and 9 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 13 May 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?
Contact Amélie K Mainjot (a.mainjot@chu.ulg.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evaluation of minimally-invasive treatment protocol of worn dentition (time frame: 5 years). The study lists 2 primary outcomes in all. 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 NCT02828696, which also lists 1 linked publication.
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 13 May 2019.