Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-01-11 @ 7:21 PM
Study NCT ID:
NCT00485602
Status:
UNKNOWN
Last Update Posted:
2007-06-13
First Post:
2007-06-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Orthodontic Treatment With a Part-Time Wearing Esthetic Removable Appliance
Sponsor:
Hadassah Medical Organization
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 patient's 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 patient's 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 doctor's 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 doctor's instructions.
Clinical examination for follow-up will be done every 4 weeks.
Study Oversight
Has Oversight DMC:
False
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?: