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

Sponsor

Shahid Beheshti University (Other)

Overall Status

Unknown status

CT.gov ID

NCT00916084

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Maxillary Deficiency	Device: Fixed Tongue Appliance Device: Fixed Face Mask	Phase 3

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Jun 1, 2009

Anticipated Primary Completion Date :

Apr 1, 2010

Anticipated Study Completion Date :

Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A	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. Other Names: tongue plate
Experimental: Group B	Device: 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. Other Names: face mask

Arm

Intervention/Treatment

Experimental: Group A

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.

Other Names:

tongue plate

Experimental: Group B

Device: 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.

Other Names:

face mask

Outcome Measures

Primary Outcome Measures

Cephalometric angles and clinical features [At least 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 11 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Growing patients
Class III with maxillary deficiency

Exclusion Criteria:

Previous orthodontic treatment
Uncooperative patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shahid Beheshti Medical University	Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

Shahid Beheshti University

Investigators

Study Chair: Rahman Showkatbakhsh, Professor, Shaheed Beheshti dental school
Principal Investigator: Mohammad Behnaz, Shahid Beheshti Dental school

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00916084

Other Study ID Numbers:

behnaz1357

First Posted:

Jun 9, 2009

Last Update Posted:

Jul 27, 2010

Last Verified:

Dec 1, 2009

Additional relevant MeSH terms:

Micrognathism

Study Results

No Results Posted as of Jul 27, 2010