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

Maxillary Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00916084
• Other study ID #: behnaz1357
• Status: Recruiting
• Phase: Phase 3
• First received: June 8, 2009
• Last updated: July 26, 2010
• Start date: June 2009
• Est. completion date: August 2010

Study information

• Verified date: December 2009
• Source: Shahid Beheshti University
• Contact: Mohammad Behnaz, Orthodontist
• Phone: 09123278021
• Email: behnaz1357[@]yahoo.com
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 11 Years

Eligibility

Inclusion Criteria:

• Growing patients

• Class III with maxillary deficiency

Exclusion Criteria:

• Previous orthodontic treatment

• Uncooperative patients

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Maxillary Deficiency

Intervention

Device:
• Fixed Tongue Appliance
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.
• Fixed Face Mask
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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shahid Beheshti Medical University	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cephalometric angles and clinical features		At least 6 months	Yes