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Orthodontic Treatment With a Part-Time Wearing Esthetic Removable Appliance

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2007 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00485602
First Posted: June 13, 2007
Last Update Posted: July 25, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  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 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 68 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


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

Locations
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         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Meir Redlich Hadassah Medical Organization
  More Information

ClinicalTrials.gov Identifier: NCT00485602     History of Changes
Other Study ID Numbers: RAFENALIGN-HMO-CTIL
First Submitted: June 12, 2007
First Posted: June 13, 2007
Last Update Posted: July 25, 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