Orthodontic Treatment With a Part-Time Wearing Esthetic Removable Appliance

Sponsor

Hadassah Medical Organization (Other)

Overall Status

Unknown status

CT.gov ID

NCT00485602

Collaborator

(none)

Enrollment

Location

Study Details

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

Anticipated Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Dec 1, 2007

Outcome Measures

Primary Outcome Measures

study models [every 2 appointments (8 weeks)]

Secondary Outcome Measures

occlusal photographs [every 3 appointments (12 weeks)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 68 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Hadassah Medical Organization	Jerusalem		Israel	91120

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator: Meir Redlich, Hadassah Medical Organization

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00485602

Other Study ID Numbers:

RAFENALIGN-HMO-CTIL

First Posted:

Jun 13, 2007

Last Update Posted:

Jun 13, 2007

Last Verified:

Jun 1, 2007

Keywords provided by , ,

orthodontic treatment

Additional relevant MeSH terms:

Malocclusion

Study Results

No Results Posted as of Jun 13, 2007