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Orthodontic Treatment With a Part-Time Wearing Esthetic Removable Appliance
Recruitment status was: Not yet recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Malocclusion | Procedure: orthodontic treatment with "Rafenalign" appliance | Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized 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) ]
| Estimated Enrollment: | 20 |
| 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.
Eligibility| Ages Eligible for Study: | 8 Years to 68 Years (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00485602
| Contact: Meir Redlich, PhD DMD | 0097226776184 | mredlich@zahav.net.il |
| Israel | |
| Hadassah Medical Organization | Not yet recruiting |
| Jerusalem, Israel, 91120 | |
| Contact: Arik Tzukert, DMD 0097226776095 arik@hadassah.org.il | |
| Contact: Hadas Lemberg, PhD 0097226777572 lhadas@hadassah.org.il | |
| Principal Investigator: Meir Redlich, PhD DMD | |
| Principal Investigator: | Meir Redlich | Hadassah Medical Organization |
More Information
| ClinicalTrials.gov Identifier: | NCT00485602 History of Changes |
| Other Study ID Numbers: |
RAFENALIGN-HMO-CTIL |
| Study First Received: | June 12, 2007 |
| Last Updated: | June 12, 2007 |
Keywords provided by Hadassah Medical Organization:
|
malocclusion aligner crowding expansion orthodontic treatment |
Additional relevant MeSH terms:
|
Malocclusion Tooth Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on July 21, 2017