Orthodontic Treatment With a Part-Time Wearing Esthetic Removable Appliance

NCT ID: NCT00485602

Last Updated: 2007-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Brief Summary

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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

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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.

Conditions

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Malocclusion

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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orthodontic treatment with "Rafenalign" appliance

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Principal Investigators

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Meir Redlich

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status

Countries

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Israel

Central Contacts

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Meir Redlich, PhD DMD

Role: CONTACT

0097226776184

Facility Contacts

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Arik Tzukert, DMD

Role: primary

0097226776095

Hadas Lemberg, PhD

Role: backup

0097226777572

Other Identifiers

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RAFENALIGN-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id