Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06266130
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-02-12
Brief Title:
Digital Bonding vs Direct Bonding Study
Sponsor:
3M
Organization:
3M
Study Overview
Official Title:
A Randomized Controlled Two-arm Clinical Study to Evaluate Clinical Efficiency of 3MTM Digital Bonding Versus Direct Bonding
Status:
RECRUITING
Status Verified Date:
2024-09
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 is a prospective 2-armed randomized multi-site clinical study to demonstrate that digital bonding is a more efficient treatment method than direct placement of brackets
Detailed Description:
Traditional Direct bonding bonds each bracket tooth by tooth individually 3M digital bonding tray is a custom device which can have brackets pre-loaded according to the pre-determined placement by orthodontist prior to patients arrival to the bonding appointment This new bonding method allows orthodontist to bond an entire arch of brackets at once significantly reducing chair time for patients It is anticipated that patients in digital bonding group have shorter time spent for bonding brackets less chair time and fewer adjustment visits than those in direct bonding group
The treatment arm utilizes a combination of the Digital Bonding Tray and pre adhesive-coated Brackets
The study control arm will utilize the sites standard of care brackets pre-adhesive-coated or non-coated directly and individually applied to teeth Roughly half of sites will utilize pre-coated brackets and the remaining sites will use uncoated brackets
The treatment arm utilizes a combination of the Digital Bonding Tray and pre adhesive-coated Brackets
The study control arm will utilize the sites standard of care brackets pre-adhesive-coated or non-coated directly and individually applied to teeth Roughly half of sites will utilize pre-coated brackets and the remaining sites will use uncoated brackets
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None