Comparative Results of Maxillary Deficiency Treatment by Fixed Tongue Appliance and Fixed Facemask in Growing Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00916084
Recruitment Status : Unknown
Verified December 2009 by Shahid Beheshti University.
Recruitment status was:  Recruiting
First Posted : June 9, 2009
Last Update Posted : July 27, 2010
Information provided by:
Shahid Beheshti University

Brief Summary:
A new fixed appliance will be used to transfer the tongue force during its physiological activity to advance the nasomaxillary complex; this method will be compared with the traditional method which uses a facemask with a fixed appliance in the mouth.

Condition or disease Intervention/treatment Phase
Maxillary Deficiency Device: Fixed Tongue Appliance Device: Fixed Face Mask Phase 3

Detailed Description:
The above method will be compared with traditional one which uses the facemask in combination with an intra-oral fixed appliance.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: This Study is to Apply the Tongue Force to Correct the Dentofacial Deformities
Study Start Date : June 2009
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : August 2010

Arm Intervention/treatment
Experimental: Group A Device: Fixed Tongue Appliance
A functional appliance used for maxillary protraction. It has two bands on first molars, expansion screw and long palatal plate in the canine area which cages the tongue and transfers the force of the tongue during physiological activity to the upper arch.
Other Name: tongue plate
Experimental: Group B Device: Fixed Face Mask
An extra-oral appliance used for treatment of maxillary deficiency in growing patients. It takes anchorage from the chin and forehead, has a fixed intra-oral appliance with an expansion screw and hooks for elastics that exert a force of 300 gr. It should be used 14 hours a day.
Other Name: face mask

Primary Outcome Measures :
  1. Cephalometric angles and clinical features [ Time Frame: At least 6 months ]

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Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Growing patients
  • Class III with maxillary deficiency

Exclusion Criteria:

  • Previous orthodontic treatment
  • Uncooperative patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00916084

Contact: Mohammad Behnaz, Orthodontist 09123278021

Iran, Islamic Republic of
Shahid Beheshti Medical University Recruiting
Tehran, Iran, Islamic Republic of
Contact: Mohammad Behnaz    09123278021   
Principal Investigator: Mohammad Behnaz, Orthodontist         
Sponsors and Collaborators
Shahid Beheshti University
Study Chair: Rahman Showkatbakhsh, Professor Shaheed Beheshti dental school
Principal Investigator: Mohammad Behnaz Shahid Beheshti Dental school

Responsible Party: Shahid Beheshti Medical University Identifier: NCT00916084     History of Changes
Other Study ID Numbers: behnaz1357
First Posted: June 9, 2009    Key Record Dates
Last Update Posted: July 27, 2010
Last Verified: December 2009

Additional relevant MeSH terms:
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities