Tooth Wear:m Tooth Wear : Diagnosis- Treatment Decision

NCT ID: NCT03540264

Last Updated: 2019-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-26

Study Completion Date

2020-12-31

Brief Summary

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Tooth wear is a physiological process occurring from normal functioning of the dentition throughout lifetime.

Detailed Description

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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

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Dental Wear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The statistician will be blind to the treatment assigned to indivivual patients.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Clearfil Majesty TM

Intervention Type DEVICE

Tooth wear - composite resin

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.

Group Type ACTIVE_COMPARATOR

Vita-Enamic®

Intervention Type DEVICE

Tooth wear - polymer-infiltrated-ceramic-network

Interventions

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Clearfil Majesty TM

Tooth wear - composite resin

Intervention Type DEVICE

Vita-Enamic®

Tooth wear - polymer-infiltrated-ceramic-network

Intervention Type DEVICE

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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De Carvalho Joana, Dentist, Pr

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

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Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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DE CARVALHO Joana, Dentist, Pr

Role: CONTACT

0032 2 764 ext. 5866

Kanaan Mireille, Dentist

Role: CONTACT

0032 2 486 32 ext. 2662

Facility Contacts

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De Carvalho Joana, Dentist, Pr

Role: primary

0032 2 764 ext. 5866

Kanaan Mireille, Dentist

Role: backup

0032 2764 ext. 5866

Other Identifiers

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2017/24NOV/531

Identifier Type: -

Identifier Source: org_study_id

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