Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00485602
Status:
UNKNOWN
Last Update Posted:
2007-06-13
First Post:
2007-06-12
Brief Title:
Orthodontic Treatment With a Part-Time Wearing Esthetic Removable Appliance
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2007-06
Last Known Status:
NOT_YET_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:
None
Brief Summary:
The trial is aimed to investigate an orthodontic treatment with a new removable-part-time-wearing appliance based on High-Tech technology
The appliance should be wear only 12-14 hours a day and is made of a single silicone aligner made specifically for the patient using 3-D screening technology of the patients malocclusion The aligner has a designed pathway built-in for the tooth to move from the original position of the malocclusion to the end point - the correct position
The force system that is needed in order to generate tooth movement is produced by tiny air-balloons which are incorporated in the aligner
The study hypothesis is that an orthodontic treatment can be done successfully with this part-time wearing appliance
The appliance should be wear only 12-14 hours a day and is made of a single silicone aligner made specifically for the patient using 3-D screening technology of the patients malocclusion The aligner has a designed pathway built-in for the tooth to move from the original position of the malocclusion to the end point - the correct position
The force system that is needed in order to generate tooth movement is produced by tiny air-balloons which are incorporated in the aligner
The study hypothesis is that an orthodontic treatment can be done successfully with this part-time wearing appliance
Detailed Description:
The appliance include
silicone aligner made specifically for the patient
simple air pump to blow air in the tiny balloons
The patient is guided to wear the appliance 12-14 hours a day after filling air in the balloons under the doctors instructions
Clinical examination for follow-up will be done every 4 weeks
silicone aligner made specifically for the patient
simple air pump to blow air in the tiny balloons
The patient is guided to wear the appliance 12-14 hours a day after filling air in the balloons under the doctors instructions
Clinical examination for follow-up will be done every 4 weeks
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