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

December 18, 2008 updated by: Shahid Beheshti University of Medical Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

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 Locations

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

8 years to 14 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
  • Un cooperative 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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Reverse pull headgear

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 of Medical Sciences

Investigators

  • Study Chair: Lida Toomarian, Shaheed Beheshti dental school
  • Study Director: Rahman Showkatbakhsh, Shaheed Beheshti dental shool
  • Principal Investigator: Mahkameh Mirkarimi, Shaheed Beheshti dental shool

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

September 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

August 20, 2007

First Submitted That Met QC Criteria

August 20, 2007

First Posted (Estimate)

August 22, 2007

Study Record Updates

Last Update Posted (Estimate)

December 19, 2008

Last Update Submitted That Met QC Criteria

December 18, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13425678
  • 1234567

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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