Dental WearNCT03540264
Tooth Wear:m Tooth Wear : Diagnosis- Treatment Decision
A study testing Clearfil Majesty TM and Vita-Enamic® in people with Dental Wear, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Tooth wear is a physiological process occurring from normal functioning of the dentition throughout lifetime. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Wear
- What is being tested?
- Clearfil Majesty TM and Vita-Enamic®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Feb 2018to 31 Dec 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older, in good general health, willing to participate in the study and accepting to come to regular controls in the future.
- Patients representing any type of significant tooth wear (≥ 1 mm depth) with dentine exposure in at least 4 teeth: localized tooth wear anterior or posterior teeth and generalized tooth wear anterio and posterior teeth.
- Patients having posterior support with at least 4 molars in occlusion, 1 pair per side, excluding third molar.
Who cannot join
- Patients wearing removable partial prosthesis
- Patients presenting skeletal Cl III occlusal Relationship
- Patients with remaining clinical crown of ≤ 3 mm in height and presenting tooth anomaly in shape and number in addition to anterior diastemas.
- Patients with symptomatic temporomandibular joint disorders.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques Universitaires Saint-Luc
Brussels, 1200
De Carvalho Joana, Dentist, Pr, 0032 2 764 ext. 5866, joana.carvalho@uclouvain.be
Kanaan Mireille, Dentist, 0032 2764 ext. 5866, Mireille.kanaan@uclouvain.be
About this study
Official title: Tooth Wear : Diagnosis- Treatment Decision- Management- Monitoring- Randomized Clinical Trial
Tooth wear is a physiological process occurring from normal functioning of the dentition throughout lifetime.
Read the detailed description
The studies in the current literature indicated that both techniques of tooth preparation and the materials used are appropriate for the treatment of this condition, but the tendency is to reduce tooth preparation as reasonably possible. In this clinical trial, the investigators will compare the outcomes of direct resin composite and indirect polymer-infiltrated-ceramic-network.
- Conditions
- Dental Wear
- Being tested
- Clearfil Majesty TM, Vita-Enamic®
- Medical subject headings
- Tooth Wear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clearfil Majesty TMDevice
Tooth wear - composite resin
Vita-Enamic®Device
Tooth wear - polymer-infiltrated-ceramic-network
| Study group | Role | What they receive |
|---|---|---|
| Composite resin | Active comparator | Restoration with composite resin has shown good clinical performance and limited occlusal wear. The Clearfil Majesty will be used in the present study. Receives: Device: Clearfil Majesty TM |
| Polymer-infiltrated-ceramic-network | Active comparator | This hybrid material seems to be a promising material that imitates natural tooth properties. The VITA-Enamic® will be used in this study. Receives: Device: Vita-Enamic® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoration
by modified USPHS criteria
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start26 Feb 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental WearStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- De Carvalho Joana, Dentist, Pr, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540264
- Sponsor's protocol ID
- 2017/24NOV/531
- Status last verified
- Mar 2019
- First submitted
- 5 Mar 2018
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tooth Wear : Diagnosis- Treatment Decision- Management- Monitoring- Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03540264
- Acronym / sponsor ID
- 2017/24NOV/531
- Conditions
- Dental Wear
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 30 May 2018 (actual)
- 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.
Tooth wear is a physiological process occurring from normal functioning of the dentition throughout lifetime.
Detailed description
The studies in the current literature indicated that both techniques of tooth preparation and the materials used are appropriate for the treatment of this condition, but the tendency is to reduce tooth preparation as reasonably possible. In this clinical trial, the investigators will compare the outcomes of direct resin composite and indirect polymer-infiltrated-ceramic-network.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Composite resin | Active comparator | Device: Clearfil Majesty TMRestoration with composite resin has shown good clinical performance and limited occlusal wear. The Clearfil Majesty will be used in the present study. |
| Polymer-infiltrated-ceramic-network | Active comparator | Device: Vita-Enamic®This hybrid material seems to be a promising material that imitates natural tooth properties. The VITA-Enamic® will be used in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 years or older, in good general health, willing to participate in the study and accepting to come to regular controls in the future.
- Patients representing any type of significant tooth wear (≥ 1 mm depth) with dentine exposure in at least 4 teeth: localized tooth wear anterior or posterior teeth and generalized tooth wear anterio and posterior teeth.
- Patients having posterior support with at least 4 molars in occlusion, 1 pair per side, excluding third molar.
Key exclusion criteria (4 listed)
- Patients wearing removable partial prosthesis
- Patients presenting skeletal Cl III occlusal Relationship
- Patients with remaining clinical crown of ≤ 3 mm in height and presenting tooth anomaly in shape and number in addition to anterior diastemas.
- Patients with symptomatic temporomandibular joint disorders.
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 |
|---|---|---|
| Clearfil Majesty TMTooth wear - composite resin | Device | Composite resin |
| Vita-Enamic®Tooth wear - polymer-infiltrated-ceramic-network | Device | Polymer-infiltrated-ceramic-network |
Primary outcome
Restoration
Time frame: up to 3 years
by modified USPHS criteria
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
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Evaluation of Wear Resistance of CAD/CAM Hybrid Ceramic and Nano-Hybrid Composite Overlays in Endodontically Treated Molars and Their Effect on Natural Antagonist Teeth
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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.
De Carvalho Joana, Dentist, Pr principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clearfil Majesty TM and Vita-Enamic® in people with Dental Wear, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain 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 4 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 11 Mar 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 DE CARVALHO Joana, Dentist, Pr (0032 2 764 ext. 5866, joana.carvalho@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Restoration (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2019.