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

Sponsor
Shahid Beheshti University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT00519415
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
14
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

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
  • 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
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 :
Sep 1, 2007
Actual Primary Completion Date :
Sep 1, 2008
Actual Study Completion Date :
Nov 1, 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 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cephalometric angles and clinical features [At least 6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 14 Years
    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

    Locations

    Site City State Country Postal Code
    1 Shaheed Beheshti dental school Tehran Iran, Islamic Republic of

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00519415
    Other Study ID Numbers:
    • 13425678
    • 1234567
    First Posted:
    Aug 22, 2007
    Last Update Posted:
    Dec 19, 2008
    Last Verified:
    Dec 1, 2008
    Keywords provided by , ,
    Tongue plate
    Facemask
    class III maxillary deficiency
    orthodontic angle class three
    Additional relevant MeSH terms:
    Micrognathism

    Study Results

    No Results Posted as of Dec 19, 2008