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Orthodontic Treatment With a Part-Time Wearing Esthetic Removable Appliance

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ClinicalTrials.gov Identifier: NCT00485602
Recruitment Status : Unknown
Verified June 2007 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : June 13, 2007
Last Update Posted : June 13, 2007
Sponsor:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment Phase
Malocclusion Procedure: orthodontic treatment with "Rafenalign" appliance Phase 1 Phase 2

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Orthodontia
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: June 13, 2007    Key Record Dates
Last Update Posted: June 13, 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