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Orthodontic Treatment With a Part-Time Wearing Esthetic Removable Appliance
This study is not yet open for participant recruitment.
Verified by Hadassah Medical Organization, June 2007
First Received: June 12, 2007   No Changes Posted
Sponsored by: Hadassah Medical Organization
Information provided by: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00485602
  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 I
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Further study details as provided by Hadassah Medical Organization:

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

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

Estimated Enrollment: 20
Study Start Date: December 2007
Detailed 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.

  Eligibility

Ages Eligible for Study:   8 Years to 68 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00485602

Contacts
Contact: Meir Redlich, PhD DMD 0097226776184 mredlich@zahav.net.il

Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Meir Redlich Hadassah Medical Organization, Jerusalem, Israel
  More Information

No publications provided

Study ID Numbers: RAFENALIGN-HMO-CTIL
Study First Received: June 12, 2007
Last Updated: June 12, 2007
ClinicalTrials.gov Identifier: NCT00485602     History of Changes
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
malocclusion
aligner
crowding
expansion
orthodontic treatment

Study placed in the following topic categories:
Tooth Diseases
Malocclusion
Stomatognathic Diseases

Additional relevant MeSH terms:
Tooth Diseases
Malocclusion
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 02, 2009



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