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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Stomatognathic Diseases Tooth Diseases

ClinicalTrials.gov processed this record on February 25, 2015

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