Comparative Results of Maxillary Deficiency Treatment by Tongue Plate and 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: Completed

Administrative data

• NCT number: NCT00519415
• Other study ID #: 13425678
• Secondary ID: 1234567
• Status: Completed
• Phase: Phase 3
• First received: August 20, 2007
• Last updated: December 18, 2008
• Start date: September 2007
• Est. completion date: November 2008

Study information

• Verified date: December 2008
• Source: hahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 14 Years

Eligibility

Inclusion Criteria:

• Growing patients

• Class III with maxillary deficiency

Exclusion Criteria:

• Previous orthodontic treatment

• Un cooperative patients

Study Design

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

Related Conditions & MeSH terms

• Maxillary Deficiency

Intervention

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.
• 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shaheed Beheshti dental school	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

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