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

Tooth Wear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02828696
• Other study ID #: NP001
• Status: Recruiting
• Phase: N/A
• Start date: June 2016
• Est. completion date: December 2021

Study information

• Verified date: May 2019
• Source: University of Liege
• Contact: Amélie K Mainjot
• Email: a.mainjot[@]chu.ulg.ac.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: December 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tooth Wear

Intervention

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.

Locations

Country	Name	City	State
Belgium	Institute of Dentistry University of Liege	Liege

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical evaluation of minimally-invasive treatment protocol of worn dentition	Clinical evaluation following FDI criteria	5 years
Primary	Quality of life evaluation of minimally-invasive treatment protocol of worn dentition	Quality of life questionnaires	5 years
Secondary	Toxicology evaluation of PICN restorations mechanical and biological behaviour	Toxicology ex vivo evaluation	5 years
Secondary	Wear evaluation of PICN restorations mechanical and biological behaviour	Wear ex vivo evaluation	5 years