Minimally Invasive Treatment of Worn Dentition With Innovative CAD-CAM Composites
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 15, 2016
CompletedFirst Posted
Study publicly available on registry
July 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedMay 13, 2019
May 1, 2019
5 years
June 15, 2016
May 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Toxicology evaluation of PICN restorations mechanical and biological behaviour
5 years
Wear evaluation of PICN restorations mechanical and biological behaviour
5 years
Study Arms (1)
No prep
OTHER"No prep" treatment of worn dentition with CAD-CAM composite (PICN)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Dentistry University of Liege
Liège, 4000, Belgium
Related Publications (1)
Oudkerk J, Herman R, Eldafrawy M, Wulfman C, Ernst M, Vanheusden A, Mainjot A. Intraoral wear of PICN CAD-CAM composite restorations used in severe tooth wear treatment: 5-year results of a prospective clinical study using 3D profilometry. Dent Mater. 2024 Jul;40(7):1056-1063. doi: 10.1016/j.dental.2024.05.015. Epub 2024 May 18.
PMID: 38762399DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Amélie Mainjot
University Hospital Center (CHU) of Liège
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 15, 2016
First Posted
July 12, 2016
Study Start
June 1, 2016
Primary Completion
June 1, 2021
Study Completion
December 1, 2021
Last Updated
May 13, 2019
Record last verified: 2019-05