Orthodontic Treatment With a Part-Time Wearing Esthetic Removable Appliance

Malocclusion Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00485602
• Other study ID #: RAFENALIGN-HMO-CTIL
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: June 12, 2007
• Last updated: June 12, 2007
• Start date: December 2007

Study information

• Verified date: June 2007
• Source: Hadassah Medical Organization
• Contact: Meir Redlich, PhD DMD
• Phone: 0097226776184
• Email: mredlich[@]zahav.net.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 68 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Malocclusion

Intervention

Procedure:
• orthodontic treatment with "Rafenalign" appliance

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	study models		every 2 appointments (8 weeks)
Secondary	occlusal photographs		every 3 appointments (12 weeks)