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

Primary Purpose

Maxillary Deficiency

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Tongue plate
Facemask
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Maxillary Deficiency focused on measuring Tongue plate, Facemask, class III maxillary deficiency, orthodontic angle class three

Eligibility Criteria

8 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Growing patients
  • Class III with maxillary deficiency

Exclusion Criteria:

  • Previous orthodontic treatment
  • Un cooperative patients

Sites / Locations

  • Shaheed Beheshti dental school

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Cephalometric angles and clinical features

Secondary Outcome Measures

Full Information

First Posted
August 20, 2007
Last Updated
December 18, 2008
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00519415
Brief Title
Comparative Results of Maxillary Deficiency Treatment by Tongue Plate and Facemask in Growing Patients
Official Title
This Study is to Apply the Tongue Force to Correct the Dentofacial Deformities
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. 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.
Detailed Description
The above method will be compared with traditional one which uses the Facemask in combination with an intra-oral appliance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maxillary Deficiency
Keywords
Tongue plate, Facemask, class III maxillary deficiency, orthodontic angle class three

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Tongue plate
Other Intervention Name(s)
tongue appliance
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Facemask
Other Intervention Name(s)
Reverse pull headgear
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cephalometric angles and clinical features
Time Frame
At least 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Growing patients Class III with maxillary deficiency Exclusion Criteria: Previous orthodontic treatment Un cooperative patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lida Toomarian
Organizational Affiliation
Shaheed Beheshti dental school
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rahman Showkatbakhsh
Organizational Affiliation
Shaheed Beheshti dental shool
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mahkameh Mirkarimi
Organizational Affiliation
Shaheed Beheshti dental shool
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaheed Beheshti dental school
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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