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
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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 |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Study Start Date : | December 2007 |

- study models [ Time Frame: every 2 appointments (8 weeks) ]
- occlusal photographs [ Time Frame: every 3 appointments (12 weeks) ]

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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

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 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 |
ClinicalTrials.gov Identifier: | NCT00485602 History of Changes |
Other Study ID Numbers: |
RAFENALIGN-HMO-CTIL |
First Posted: | June 13, 2007 Key Record Dates |
Last Update Posted: | June 13, 2007 |
Last Verified: | June 2007 |
Keywords provided by Hadassah Medical Organization:
malocclusion aligner crowding expansion orthodontic treatment |
Additional relevant MeSH terms:
Malocclusion Tooth Diseases Stomatognathic Diseases |