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

May 9, 2019 updated by: Mainjot Amélie, University of Liege
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Liege, Belgium, 4000
        • Recruiting
        • Institute of Dentistry University of Liege
        • Contact:
        • Sub-Investigator:
          • Julie Oudkerk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical evaluation of minimally-invasive treatment protocol of worn dentition
Time Frame: 5 years
Clinical evaluation following FDI criteria
5 years
Quality of life evaluation of minimally-invasive treatment protocol of worn dentition
Time Frame: 5 years
Quality of life questionnaires
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicology evaluation of PICN restorations mechanical and biological behaviour
Time Frame: 5 years
Toxicology ex vivo evaluation
5 years
Wear evaluation of PICN restorations mechanical and biological behaviour
Time Frame: 5 years
Wear ex vivo evaluation
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Liege

Investigators

  • Study Director: Amélie Mainjot, University Hospital Center (CHU) of Liège

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

June 15, 2016

First Submitted That Met QC Criteria

July 6, 2016

First Posted (Estimate)

July 12, 2016

Study Record Updates

Last Update Posted (Actual)

May 13, 2019

Last Update Submitted That Met QC Criteria

May 9, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NP001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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