Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-03-11 @ 11:38 PM
Study NCT ID:
NCT02957734
Status:
UNKNOWN
Last Update Posted:
2021-09-23
First Post:
2016-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Full Occlusal Rehabilitation for Patients With Severe Tooth Wear Using Indirect Composite Restorations
Sponsor:
Radboud University Medical Center
Organization:
Study Overview
Official Title:
The Use of LAVA Ultimate Restorations in a Full Occlusal Rehabilitation for Patients With Severe Tooth Wear
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NTWP
Brief Summary:
LAVA Ultimate composite restorations will be used as restorative material to reconstruct severely worn dentitions.
Detailed Description:
Standard dental treatment will be provided to the patients with severely worn dentitions. Treatment is based on the principles of 'minimally invasive treatment techniques'.
Main difference with the 'standard' treatment protocol and the standard procedure of placing composite restorations is the fully digital workflow. In the traditional workflow a silicon impression is made, after which the dental technician produces the (indirect) composite restorations in by hand. These restorations are then adhesively cemented on the teeth by the dentist. In the fully digital workflow, digital 3D-scans are made using the 3D LAVA scanner (3M ESPE). Based on these digital 3D-images a digital wax-up is made by the dental technician after which all composite restorations (uplays and backings) are designed digitally before being milled and finally adhesively cemented on the teeth by the dentists. An important benefit for the patients is the rehabilitation of their worn dentitions. Functionality (teeth are less sensitive, improved chewing ability, a better occlusal stability, etc) and aesthetics will be improved immediately after finishing the treatment. Moreover, the estimated treatment time will be less (estimated treatment time approx. 12hours) than the traditional methods when using the standard treatment protocol (estimated treatment time approx. 18hours).
Another potential benefit is a better control and more predictable results by using 3D-images with the pre-designed computer simulation.
A risk of these indirect composite resin restorations is the unknown survival rate compared to other indirect as well as to direct application technique
Main difference with the 'standard' treatment protocol and the standard procedure of placing composite restorations is the fully digital workflow. In the traditional workflow a silicon impression is made, after which the dental technician produces the (indirect) composite restorations in by hand. These restorations are then adhesively cemented on the teeth by the dentist. In the fully digital workflow, digital 3D-scans are made using the 3D LAVA scanner (3M ESPE). Based on these digital 3D-images a digital wax-up is made by the dental technician after which all composite restorations (uplays and backings) are designed digitally before being milled and finally adhesively cemented on the teeth by the dentists. An important benefit for the patients is the rehabilitation of their worn dentitions. Functionality (teeth are less sensitive, improved chewing ability, a better occlusal stability, etc) and aesthetics will be improved immediately after finishing the treatment. Moreover, the estimated treatment time will be less (estimated treatment time approx. 12hours) than the traditional methods when using the standard treatment protocol (estimated treatment time approx. 18hours).
Another potential benefit is a better control and more predictable results by using 3D-images with the pre-designed computer simulation.
A risk of these indirect composite resin restorations is the unknown survival rate compared to other indirect as well as to direct application technique
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: