Orthodontic Treatment With a Part-Time Wearing Esthetic Removable Appliance
- Conditions
- Malocclusion
- Registration Number
- NCT00485602
- Lead Sponsor
- Hadassah Medical Organization
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- mild to moderate class I malocclusion
- good general health
- good oral hygiene
- bad cooperation
- any mental or health problem
- severe class I malocclusion, class II or class III malocclusion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method study models every 2 appointments (8 weeks)
- Secondary Outcome Measures
Name Time Method occlusal photographs every 3 appointments (12 weeks)
Trial Locations
- Locations (1)
Hadassah Medical Organization
🇮🇱Jerusalem, Israel