Orthodontic Treatment With a Part-Time Wearing Esthetic Removable Appliance
Recruitment status was: Not yet recruiting
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.
Procedure: orthodontic treatment with "Rafenalign" appliance
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- study models [ Time Frame: every 2 appointments (8 weeks) ]
- occlusal photographs [ Time Frame: every 3 appointments (12 weeks) ]
|Study Start Date:||December 2007|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00485602
|Hadassah Medical Organization|
|Jerusalem, Israel, 91120|
|Principal Investigator:||Meir Redlich||Hadassah Medical Organization|