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Orthodontic Treatment With a Part-Time Wearing Esthetic Removable Appliance

Primary Purpose

Malocclusion

Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
orthodontic treatment with "Rafenalign" appliance
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion focused on measuring malocclusion, aligner, crowding, expansion, orthodontic treatment

Eligibility Criteria

8 Years - 68 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hadassah Medical Organization

Outcomes

Primary Outcome Measures

study models

Secondary Outcome Measures

occlusal photographs

Full Information

First Posted
June 12, 2007
Last Updated
June 12, 2007
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00485602
Brief Title
Orthodontic Treatment With a Part-Time Wearing Esthetic Removable Appliance
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Unknown status
Study Start Date
December 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion
Keywords
malocclusion, aligner, crowding, expansion, orthodontic treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
orthodontic treatment with "Rafenalign" appliance
Primary Outcome Measure Information:
Title
study models
Time Frame
every 2 appointments (8 weeks)
Secondary Outcome Measure Information:
Title
occlusal photographs
Time Frame
every 3 appointments (12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meir Redlich, PhD DMD
Phone
0097226776184
Email
mredlich@zahav.net.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meir Redlich
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arik Tzukert, DMD
Phone
0097226776095
Email
arik@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Hadas Lemberg, PhD
Phone
0097226777572
Email
lhadas@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Meir Redlich, PhD DMD

12. IPD Sharing Statement

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Orthodontic Treatment With a Part-Time Wearing Esthetic Removable Appliance

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