Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT04326816
Status:
COMPLETED
Last Update Posted:
2021-03-18
First Post:
2020-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Restorative Treatment of Severe Tooth Wear; Direct vs Indirect
Sponsor:
Radboud University Medical Center
Organization:
Study Overview
Official Title:
Restorative Treatment of Severe Tooth Wear; Direct vs Indirect
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
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:
None
Brief Summary:
This study compares the survival rates of both direct and indirect resin-based composite restorations in the treatment of severe tooth wear.
Detailed Description:
Tooth wear can lead to pain, discomfort and unsatisfying dental attractiveness and when severe, it can compromise the dentition's prognosis. Restorative therapies for treatment of severe tooth wear should be preferably minimally invasive and adhesive.
This study compares two different treatment techniques for severe tooth wear. The first technique is regarded as the 'standard' technique. This is a full rehabilitation using only direct composite restorations (AP-X, Kuraray, Japan).
The second technique comprises a full rehabilitation using both direct and indirect resin composite restorations (Estenia C\&B, Kuraray, Japan). 10 indirect restorations are placed on specific elements i.e. first molars and palatal sides of all maxillary anterior teeth. Other elements are restored conform the direct protocol.
An important benefit for the patients is the rehabilitation of their worn dentitions. Functionality (teeth are less sensitive, improved chewing ability, better occlusal stability, etc) and aesthetics will be improved immediately after finishing the treatment.
Indirect techniques have the advantage of a superior control over form of restorations.
This study compares two different treatment techniques for severe tooth wear. The first technique is regarded as the 'standard' technique. This is a full rehabilitation using only direct composite restorations (AP-X, Kuraray, Japan).
The second technique comprises a full rehabilitation using both direct and indirect resin composite restorations (Estenia C\&B, Kuraray, Japan). 10 indirect restorations are placed on specific elements i.e. first molars and palatal sides of all maxillary anterior teeth. Other elements are restored conform the direct protocol.
An important benefit for the patients is the rehabilitation of their worn dentitions. Functionality (teeth are less sensitive, improved chewing ability, better occlusal stability, etc) and aesthetics will be improved immediately after finishing the treatment.
Indirect techniques have the advantage of a superior control over form of restorations.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: