Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06539676
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-28
Brief Title:
A Study to Compare Nighttime Aligners to Daytime Aligners
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Two-armed Multicenter Clinical Study to Evaluate Efficacy Performance and Safety of Nighttime Aligners Worn 10-12 Hours Day or Night Compared to Daytime Aligners Worn 20-22 Hours DayNight
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
The purpose of this research study is to see if Nighttime Aligners worn 10-12 hours per day or night are effective and safe for tooth movement and if so how they compare with the standard Daytime aligners worn 20-22 hours per day in adults and children from 12 years of age and older
It will investigate the efficacy and performance of the treatments as well as the safety of the investigational device and comparator
The main objectives are
Comparison between the two groups concerning actual vs planned tooth movements measured by changes in tooth position
Comparison between the two groups concerning the incidence of device or dental related AEs
Overall dentist and participant satisfaction with the treatment
Participants will
Be given orthodontic aligner therapy with the Daytime 20-22hday or Nighttime 10-12hday Aligners randomly assigned
Attend approximately 5 study during approximately 8-10 months
It will investigate the efficacy and performance of the treatments as well as the safety of the investigational device and comparator
The main objectives are
Comparison between the two groups concerning actual vs planned tooth movements measured by changes in tooth position
Comparison between the two groups concerning the incidence of device or dental related AEs
Overall dentist and participant satisfaction with the treatment
Participants will
Be given orthodontic aligner therapy with the Daytime 20-22hday or Nighttime 10-12hday Aligners randomly assigned
Attend approximately 5 study during approximately 8-10 months
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