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Orthodontic Treatment With a Part-Time Wearing Esthetic Removable Appliance

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00485602
First received: June 12, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Orthodontia
U.S. FDA Resources

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 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

No publications provided

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

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

Additional relevant MeSH terms:
Malocclusion
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on June 17, 2013