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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2009 by Shahid Beheshti University.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: June 9, 2009
Last Update Posted: July 27, 2010
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.
Information provided by:
Shahid Beheshti University
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 Intervention Phase
Maxillary Deficiency Device: Fixed Tongue Appliance Device: Fixed Face Mask Phase 3

Study Type: Interventional
Study Design: 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

Further study details as provided by Shahid Beheshti University:

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

Estimated Enrollment: 20
Study Start Date: June 2009
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00916084

Contact: Mohammad Behnaz, Orthodontist 09123278021 behnaz1357@yahoo.com

Iran, Islamic Republic of
Shahid Beheshti Medical University Recruiting
Tehran, Iran, Islamic Republic of
Contact: Mohammad Behnaz    09123278021    Behnaz1357@yahoo.com   
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
  More Information

Responsible Party: Shahid Beheshti Medical University
ClinicalTrials.gov Identifier: NCT00916084     History of Changes
Other Study ID Numbers: behnaz1357
First Submitted: June 8, 2009
First Posted: June 9, 2009
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