Malocclusion
Conditions
Keywords
malocclusion, aligner, crowding, expansion, orthodontic treatment
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.
Interventions
PROCEDUREorthodontic treatment with Rafenalign appliance
Sponsors
Hadassah Medical Organization
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 68 Years
Healthy volunteers
Yes
Inclusion criteria
* mild to moderate class I malocclusion * good general health * good oral hygiene
Exclusion criteria
* bad cooperation * any mental or health problem * severe class I malocclusion, class II or class III malocclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| study models | every 2 appointments (8 weeks) |
Secondary
| Measure | Time frame |
|---|---|
| occlusal photographs | every 3 appointments (12 weeks) |
Countries
Israel
Contacts
Primary ContactMeir Redlich, PhD DMD
Outcome results
None listed