Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518447
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-03
Brief Title:
Conventional vs Digital CADCAM Splints for Bruxism
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Cross-clinical Trial Comparing Precision of Conventional Stabilization Splints Michigan Type Versus CADCAM Splints With Fully Digital Flow
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized controlled trial with a crossover design which intends to enroll 20 adult patients aged between 20 and 55 years with confirmed or probable sleep bruxism Participants will be randomized to receive either a conventional stabilization splint or a CADCAM splint Each patient will use one type of splint for 30 days followed by a 15-day wash-out period after which they will switch to the other type of splint The study aims to compare the quality precision and comfort of the two types of occlusal splints Outcomes will include manufacturing time amount of in-mouth adjustments adaptation occlusal contacts and participant satisfaction
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None