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

This study has been completed.
Sponsor:
Information provided by:
Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00519415
First received: August 20, 2007
Last updated: December 18, 2008
Last verified: December 2008
History of Changes
  Purpose

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 Intervention Phase
Maxillary Deficiency
 Other: Tongue plate
Other: Facemask
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
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 Shaheed Beheshti Medical University:

Primary Outcome Measures:
  • Cephalometric angles and clinical features [ Time Frame: At least 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: September 2007
Study Completion Date: November 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   8 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Growing patients
  • Class III with maxillary deficiency

Exclusion Criteria:

  • Previous orthodontic treatment
  • Un cooperative patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00519415

Locations
Iran, Islamic Republic of
Shaheed Beheshti dental school
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Shaheed Beheshti Medical University
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
  More Information

No publications provided

Responsible Party: Mahkameh Mirkarimi, Shaheed Beheshti University
ClinicalTrials.gov Identifier: NCT00519415     History of Changes
Other Study ID Numbers: 13425678, 1234567
Study First Received: August 20, 2007
Last Updated: December 18, 2008
Health Authority: Iran: Ethics Committee

Keywords provided by Shaheed Beheshti Medical University:
Tongue plate
Facemask
class III maxillary deficiency
orthodontic angle class three

ClinicalTrials.gov processed this record on June 18, 2013