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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

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

NCT ID

NCT00485602

First Posted

June 12, 2007

Last Updated

June 12, 2007

Sponsor

Hadassah Medical Organization

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

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

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

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

arik@hadassah.org.il

First Name & Middle Initial & Last Name & Degree

Hadas Lemberg, PhD

Phone

0097226777572

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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