Orthodontic Treatment With a Part-Time Wearing Esthetic Removable Appliance - Tabular View

Tracking Information

First Received Date ^ICMJE

June 12, 2007

Last Updated Date

June 12, 2007

Start Date ^ICMJE

December 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

study models [ Time Frame: every 2 appointments (8 weeks) ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

occlusal photographs [ Time Frame: every 3 appointments (12 weeks) ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Orthodontic Treatment With a Part-Time Wearing Esthetic Removable Appliance

Official Title ^ICMJE

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.

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Malocclusion

Intervention ^ICMJE

Procedure: orthodontic treatment with "Rafenalign" appliance

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

8 Years to 68 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Meir Redlich, PhD DMD

0097226776184

mredlich@zahav.net.il

Location Countries ^ICMJE

Israel

Administrative Information

NCT ID ^ICMJE

NCT00485602

Responsible Party

Study ID Numbers ^ICMJE

RAFENALIGN-HMO-CTIL

Study Sponsor ^ICMJE

Hadassah Medical Organization

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Meir Redlich

Hadassah Medical Organization, Jerusalem, Israel

Information Provided By

Hadassah Medical Organization

Verification Date

June 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP