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

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ClinicalTrials.gov Identifier: NCT02828696
Recruitment Status : Unknown
Verified May 2019 by Mainjot Amélie, University of Liege.
Recruitment status was:  Recruiting
First Posted : July 12, 2016
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Mainjot Amélie, University of Liege

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tooth Wear Device: "No prep" treatment of worn dentition with CAD-CAM composite Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Minimally Invasive Treatment of Worn Dentition With Innovative CAD-CAM Composites
Study Start Date : June 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021
Arms and Interventions
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Arm Intervention/treatment
No prep
"No prep" treatment of worn dentition with CAD-CAM composite (PICN)
 Device: "No prep" treatment of worn dentition with CAD-CAM composite
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.


Outcome Measures
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Primary Outcome Measures :
  1. Clinical evaluation of minimally-invasive treatment protocol of worn dentition [ Time Frame: 5 years ]
    Clinical evaluation following FDI criteria

  2. Quality of life evaluation of minimally-invasive treatment protocol of worn dentition [ Time Frame: 5 years ]
    Quality of life questionnaires


Secondary Outcome Measures :
  1. Toxicology evaluation of PICN restorations mechanical and biological behaviour [ Time Frame: 5 years ]
    Toxicology ex vivo evaluation

  2. Wear evaluation of PICN restorations mechanical and biological behaviour [ Time Frame: 5 years ]
    Wear ex vivo evaluation


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 :

    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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02828696


Contacts
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Contact: Amélie K Mainjot a.mainjot@chu.ulg.ac.be
Contact: Julie Oudkerk oudkerk.julie@gmail.com

Locations
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Belgium
Institute of Dentistry University of Liege Recruiting
Liege, Belgium, 4000
Contact: Amélie K Mainjot       a.mainjot@chu.ulg.ac.be   
Sub-Investigator: Julie Oudkerk         
Sponsors and Collaborators
University of Liege
Investigators
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Study Director: Amélie Mainjot University Hospital Center (CHU) of Liège
More Information
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Responsible Party: Mainjot Amélie, Professor, University of Liege
ClinicalTrials.gov Identifier: NCT02828696    
Other Study ID Numbers: NP001
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Mainjot Amélie, University of Liege:
CAD-CAM composites
Worn dentition
minimally invasive treatment
Additional relevant MeSH terms:
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Tooth Wear
Tooth Diseases
Stomatognathic Diseases