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

July 26, 2010 updated by: Shahid Beheshti University

This Study is to Apply the Tongue Force to Correct the Dentofacial Deformities

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of
        • Recruiting
        • Shahid beheshti medical University
        • Contact:
        • Principal Investigator:
          • Mohammad Behnaz, Orthodontist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 11 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Growing patients
  • Class III with maxillary deficiency

Exclusion Criteria:

  • Previous orthodontic treatment
  • Uncooperative patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • face mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cephalometric angles and clinical features
Time Frame: At least 6 months
At least 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University

Investigators

  • Study Chair: Rahman Showkatbakhsh, Professor, Shaheed Beheshti dental school
  • Principal Investigator: Mohammad Behnaz, Shahid Beheshti Dental school

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (ANTICIPATED)

April 1, 2010

Study Completion (ANTICIPATED)

August 1, 2010

Study Registration Dates

First Submitted

June 8, 2009

First Submitted That Met QC Criteria

June 8, 2009

First Posted (ESTIMATE)

June 9, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 27, 2010

Last Update Submitted That Met QC Criteria

July 26, 2010

Last Verified

December 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • behnaz1357

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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