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

Study Overview
=================
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.

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

Conditions
-----------------
Tooth Wear

Intervention / Treatment
-----------------
* Device: No prep treatment of worn dentition with CAD-CAM composite


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: No prep<br>No prep treatment of worn dentition with CAD-CAM composite (PICN) | Device: No prep treatment of worn dentition with CAD-CAM composite<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CAD-CAM composites, Worn dentition, minimally invasive treatment