Back to resultsComparative Results of Maxillary Deficiency Treatment by Fixed Tongue Appliance and Fixed Facemask in Growing Patients
Primary Purpose
Maxillary Deficiency
Status
Unknown status
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Fixed Tongue Appliance
Fixed Face Mask
Sponsored by
About this trial
This is an interventional treatment trial for Maxillary Deficiency
Eligibility Criteria
Inclusion Criteria:
- Growing patients
- Class III with maxillary deficiency
Exclusion Criteria:
- Previous orthodontic treatment
- Uncooperative patients
Sites / Locations
- Shahid Beheshti Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A
Group B
Arm Description
Outcomes
Primary Outcome Measures
Cephalometric angles and clinical features
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00916084
Brief Title
Comparative Results of Maxillary Deficiency Treatment by Fixed Tongue Appliance and Fixed 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 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
April 2010 (Anticipated)
Study Completion Date
August 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Shahid Beheshti University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
The above method will be compared with traditional one which uses the facemask in combination with an intra-oral fixed appliance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maxillary Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Title
Group B
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Fixed Tongue Appliance
Other Intervention Name(s)
tongue plate
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Fixed Face Mask
Other Intervention Name(s)
face mask
Intervention Description
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.
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
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Growing patients
Class III with maxillary deficiency
Exclusion Criteria:
Previous orthodontic treatment
Uncooperative patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad Behnaz, Orthodontist
Phone
09123278021
Email
behnaz1357@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rahman Showkatbakhsh, Professor
Organizational Affiliation
Shaheed Beheshti dental school
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mohammad Behnaz
Organizational Affiliation
Shahid Beheshti Dental school
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shahid Beheshti Medical University
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad Behnaz
Phone
09123278021
Email
Behnaz1357@yahoo.com
First Name & Middle Initial & Last Name & Degree
Mohammad Behnaz, Orthodontist
12. IPD Sharing Statement
Learn more about this trial
Comparative Results of Maxillary Deficiency Treatment by Fixed Tongue Appliance and Fixed Facemask in Growing Patients
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