Malocclusion Clinical Trial
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 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.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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