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

Not Applicable

• Conditions: Tooth Wear
• Interventions: Device: "No prep" treatment of worn dentition with CAD-CAM composite

• Registration Number: NCT02828696
• Lead Sponsor: University of Liege

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-15
• Study First Submitted QC: 2016-07-06
• Study First Posted: 2016-07-12
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-09
• Last Update Posted: 2019-05-13
• Primary Completion: 2021-06
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Clinical evaluation of minimally-invasive treatment protocol of worn dentition	5 years	Clinical evaluation following FDI criteria
Quality of life evaluation of minimally-invasive treatment protocol of worn dentition	5 years	Quality of life questionnaires

Secondary Outcome Measures

Name	Time	Method
Wear evaluation of PICN restorations mechanical and biological behaviour	5 years	Wear ex vivo evaluation
Toxicology evaluation of PICN restorations mechanical and biological behaviour	5 years	Toxicology ex vivo evaluation

Trial Locations

Locations (1)

Institute of Dentistry University of Liege; 🇧🇪 Liege, Belgium