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Minimally Invasive Treatment of Worn Dentition With Innovative CAD-CAM Composites

Primary Purpose

Tooth Wear

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
"No prep" treatment of worn dentition with CAD-CAM composite
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Wear focused on measuring CAD-CAM composites, Worn dentition, minimally invasive treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 :

    1. Parkinson's Disease
    2. Severe osteoarthritis
    3. 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

Sites / Locations

  • Institute of Dentistry University of LiegeRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

No prep

Arm Description

"No prep" treatment of worn dentition with CAD-CAM composite (PICN)

Outcomes

Primary Outcome Measures

Clinical evaluation of minimally-invasive treatment protocol of worn dentition
Clinical evaluation following FDI criteria
Quality of life evaluation of minimally-invasive treatment protocol of worn dentition
Quality of life questionnaires

Secondary Outcome Measures

Toxicology evaluation of PICN restorations mechanical and biological behaviour
Toxicology ex vivo evaluation
Wear evaluation of PICN restorations mechanical and biological behaviour
Wear ex vivo evaluation

Full Information

First Posted
June 15, 2016
Last Updated
May 9, 2019
Sponsor
University of Liege
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1. Study Identification

Unique Protocol Identification Number
NCT02828696
Brief Title
Minimally Invasive Treatment of Worn Dentition With Innovative CAD-CAM Composites
Official Title
Minimally Invasive Treatment of Worn Dentition With Innovative CAD-CAM Composites
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Wear
Keywords
CAD-CAM composites, Worn dentition, minimally invasive treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No prep
Arm Type
Other
Arm Description
"No prep" treatment of worn dentition with CAD-CAM composite (PICN)
Intervention Type
Device
Intervention Name(s)
"No prep" treatment of worn dentition with CAD-CAM composite
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical evaluation of minimally-invasive treatment protocol of worn dentition
Description
Clinical evaluation following FDI criteria
Time Frame
5 years
Title
Quality of life evaluation of minimally-invasive treatment protocol of worn dentition
Description
Quality of life questionnaires
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Toxicology evaluation of PICN restorations mechanical and biological behaviour
Description
Toxicology ex vivo evaluation
Time Frame
5 years
Title
Wear evaluation of PICN restorations mechanical and biological behaviour
Description
Wear ex vivo evaluation
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amélie K Mainjot
Email
a.mainjot@chu.ulg.ac.be
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Oudkerk
Email
oudkerk.julie@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amélie Mainjot
Organizational Affiliation
University Hospital Center (CHU) of Liège
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Dentistry University of Liege
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amélie K Mainjot
Email
a.mainjot@chu.ulg.ac.be
First Name & Middle Initial & Last Name & Degree
Julie Oudkerk

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Minimally Invasive Treatment of Worn Dentition With Innovative CAD-CAM Composites

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