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Status unknownNCT03540264Updated Mar 11, 2019

Tooth Wear:m Tooth Wear : Diagnosis- Treatment Decision

An interventional study of Clearfil Majesty TM and Vita-Enamic® in Dental Wear, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Status unknown at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-11.

Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

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Conditions studied

  • Dental Wear

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03

In context

Tooth Wear

62 studies on the registry are indexed under Tooth Wear; 12 are open to participants now.

This study's planned enrollment of 52 is close to the median of 49 across 41 interventional studies indexed under Tooth Wear.

Browse Tooth Wear studies →

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 350 studies on the registry; 64 are open to participants now.

Browse Cliniques universitaires Saint-Luc- Université Catholique de Louvain studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
52 participants (estimated)

Study arms

  • Active comparator
    Composite resin

    Restoration with composite resin has shown good clinical performance and limited occlusal wear. The Clearfil Majesty will be used in the present study.

    Device: Clearfil Majesty TM

  • Active comparator
    Polymer-infiltrated-ceramic-network

    This hybrid material seems to be a promising material that imitates natural tooth properties. The VITA-Enamic® will be used in this study.

    Device: Vita-Enamic®

Interventions

  • DeviceClearfil Majesty TM

    Tooth wear - composite resin

  • DeviceVita-Enamic®

    Tooth wear - polymer-infiltrated-ceramic-network

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What researchers measure

Primary outcomes

  1. Restoration

    by modified USPHS criteria

    Time frame: up to 3 years

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Study locations

1 of 1 sites recruiting
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2018 (actual). Primary completion is estimated for Dec 2020, 34 months after the start.

Of 21 interventional studies with no phase under Tooth Wear, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 30. This study's planned 34 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 5, 2018
First posted
May 30, 2018
StartActual
Feb 26, 2018
Primary completionEst.
Dec 31, 2020
CompletionEst.
Dec 31, 2020
Last update
Mar 11, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03540264
Lead sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Responsible party
Sponsor
First posted
May 30, 2018
Start date
Feb 26, 2018
Primary completion
Dec 31, 2020 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Mar 11, 2019

Study contacts

DE CARVALHO Joana, Dentist, Pr
Contact
joana.carvalho@uclouvain.be
0032 2 764 ext. 5866
Kanaan Mireille, Dentist
Contact
mireille.kanaan@uclouvain.be
0032 2 486 32 ext. 2662
De Carvalho Joana, Dentist, Pr
principal investigator · Cliniques universitaires Saint-Luc

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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