search
Back to results

Tooth Wear:m Tooth Wear : Diagnosis- Treatment Decision

Primary Purpose

Dental Wear

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Clearfil Majesty TM
Vita-Enamic®
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Wear

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cliniques Universitaires Saint-LucRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Composite resin

Polymer-infiltrated-ceramic-network

Arm Description

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

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

Outcomes

Primary Outcome Measures

Restoration
by modified USPHS criteria

Secondary Outcome Measures

Full Information

First Posted
March 5, 2018
Last Updated
March 7, 2019
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
search

1. Study Identification

Unique Protocol Identification Number
NCT03540264
Brief Title
Tooth Wear:m Tooth Wear : Diagnosis- Treatment Decision
Official Title
Tooth Wear : Diagnosis- Treatment Decision- Management- Monitoring- Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 26, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Wear

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The statistician will be blind to the treatment assigned to indivivual patients.
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Composite resin
Arm Type
Active Comparator
Arm Description
Restoration with composite resin has shown good clinical performance and limited occlusal wear. The Clearfil Majesty will be used in the present study.
Arm Title
Polymer-infiltrated-ceramic-network
Arm Type
Active Comparator
Arm Description
This hybrid material seems to be a promising material that imitates natural tooth properties. The VITA-Enamic® will be used in this study.
Intervention Type
Device
Intervention Name(s)
Clearfil Majesty TM
Intervention Description
Tooth wear - composite resin
Intervention Type
Device
Intervention Name(s)
Vita-Enamic®
Intervention Description
Tooth wear - polymer-infiltrated-ceramic-network
Primary Outcome Measure Information:
Title
Restoration
Description
by modified USPHS criteria
Time Frame
up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
DE CARVALHO Joana, Dentist, Pr
Phone
0032 2 764
Ext
5866
Email
joana.carvalho@uclouvain.be
First Name & Middle Initial & Last Name or Official Title & Degree
Kanaan Mireille, Dentist
Phone
0032 2 486 32
Ext
2662
Email
mireille.kanaan@uclouvain.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
De Carvalho Joana, Dentist, Pr
Organizational Affiliation
Cliniques universitaires Saint-Luc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussel
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
De Carvalho Joana, Dentist, Pr
Phone
0032 2 764
Ext
5866
Email
joana.carvalho@uclouvain.be
First Name & Middle Initial & Last Name & Degree
Kanaan Mireille, Dentist
Phone
0032 2764
Ext
5866
Email
Mireille.kanaan@uclouvain.be

12. IPD Sharing Statement

Learn more about this trial

Tooth Wear:m Tooth Wear : Diagnosis- Treatment Decision

We'll reach out to this number within 24 hrs