We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Comparative Results of Maxillary Deficiency Treatment by Tongue Plate and 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.
ClinicalTrials.gov Identifier: NCT00519415
Recruitment Status : Completed
First Posted : August 22, 2007
Last Update Posted : December 19, 2008
Information provided by:

Study Description
Brief Summary:
A new 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 appliance.

Condition or disease Intervention/treatment Phase
Maxillary Deficiency Other: Tongue plate Other: Facemask Phase 3

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual 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 : September 2007
Primary Completion Date : September 2008
Study Completion Date : November 2008
Arms and Interventions

Arm Intervention/treatment
Experimental: A Other: Tongue plate
A functional appliance use for maxillary protraction.It has two adams clasp and two C clasp to retained the appliance and long palatal plate in the canine area which cages the tongue and transfer the force of the tongue during physiological activity to the upper arch. It has posterior bite plate and middle screw for maxillary expansion.It should be used all the time except meal time and brushing the teeth,the acrylic appliance makes specifically for the patient.
Other Name: tongue appliance
Experimental: B Other: Facemask
An extraoral appliance use for treatment of maxillary deficiency in growing patients.It takes anchorage from chin and forehead, it has removable intraoral appliance with hooks for elastics that exerted a force of 300 gr.It should be used 14 hours a day.
Other Name: Reverse pull headgear

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   8 Years to 14 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
  • Un cooperative 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): NCT00519415

Iran, Islamic Republic of
Shaheed Beheshti dental school
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Study Chair: Lida Toomarian Shaheed Beheshti dental school
Study Director: Rahman Showkatbakhsh Shaheed Beheshti dental shool
Principal Investigator: Mahkameh Mirkarimi Shaheed Beheshti dental shool
More Information

Responsible Party: Mahkameh Mirkarimi, Shaheed Beheshti University
ClinicalTrials.gov Identifier: NCT00519415     History of Changes
Other Study ID Numbers: 13425678
First Posted: August 22, 2007    Key Record Dates
Last Update Posted: December 19, 2008
Last Verified: December 2008

Keywords provided by Shahid Beheshti University of Medical Sciences:
Tongue plate
class III maxillary deficiency
orthodontic angle class three

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