Orthodontic Treatment With a Part-Time Wearing Esthetic Removable Appliance

Hadassah Medical Center

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Malocclusion

Treatments: Procedure: orthodontic treatment with "Rafenalign" appliance

Study type: Interventional

Funder types: Other

Identifiers

NCT00485602

RAFENALIGN-HMO-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 8 to 68 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)