Orthodontic Treatment With a Part-Time Wearing Esthetic Removable Appliance
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|ClinicalTrials.gov Identifier: NCT00485602|
Recruitment Status : Unknown
Verified June 2007 by Hadassah Medical Organization.
Recruitment status was: Not yet recruiting
First Posted : June 13, 2007
Last Update Posted : June 13, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Malocclusion||Procedure: orthodontic treatment with "Rafenalign" appliance||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||December 2007|
- study models [ Time Frame: every 2 appointments (8 weeks) ]
- occlusal photographs [ Time Frame: every 3 appointments (12 weeks) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00485602
|Contact: Meir Redlich, PhD DMDfirstname.lastname@example.org|
|Hadassah Medical Organization||Not yet recruiting|
|Jerusalem, Israel, 91120|
|Contact: Arik Tzukert, DMD 0097226776095 email@example.com|
|Contact: Hadas Lemberg, PhD 0097226777572 firstname.lastname@example.org|
|Principal Investigator: Meir Redlich, PhD DMD|
|Principal Investigator:||Meir Redlich||Hadassah Medical Organization|