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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Shahid Beheshti University.
Recruitment status was  Recruiting
Information provided by:
Shahid Beheshti University Identifier:
First received: June 8, 2009
Last updated: July 26, 2010
Last verified: December 2009
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 Blind (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 ] [ Designated as safety issue: Yes ]

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.

Ages Eligible for Study:   7 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Growing patients
  • Class III with maxillary deficiency

Exclusion Criteria:

  • Previous orthodontic treatment
  • Uncooperative patients
  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 identifier: 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
  More Information

No publications provided

Responsible Party: Shahid Beheshti Medical University Identifier: NCT00916084     History of Changes
Other Study ID Numbers: behnaz1357 
Study First Received: June 8, 2009
Last Updated: July 26, 2010
Health Authority: Iran: Ethics Committee processed this record on February 11, 2016