Clinical Trial: Orthodontic Treatment With a Part-Time Wearing Esthetic Removable Appliance

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title:

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 Summary:

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.


Sponsor: Hadassah Medical Organization

Current Primary Outcome: study models [ Time Frame: every 2 appointments (8 weeks) ]

Original Primary Outcome: Same as current

Current Secondary Outcome: occlusal photographs [ Time Frame: every 3 appointments (12 weeks) ]

Original Secondary Outcome: Same as current

Information By: Hadassah Medical Organization

Dates:
Date Received: June 12, 2007
Date Started: December 2007
Date Completion:
Last Updated: June 12, 2007
Last Verified: June 2007