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

NCT ID: NCT00916084

Last Updated: 2010-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-08-31

Brief Summary

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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

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

Conditions

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Maxillary Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Group A

Group Type EXPERIMENTAL

Fixed Tongue Appliance

Intervention Type DEVICE

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.

Group B

Group Type EXPERIMENTAL

Fixed Face Mask

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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tongue plate face mask

Eligibility Criteria

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Inclusion Criteria

* Growing patients
* Class III with maxillary deficiency

Exclusion Criteria

* Previous orthodontic treatment
* Uncooperative patients
Minimum Eligible Age

7 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shahid Beheshti University

OTHER

Sponsor Role lead

Responsible Party

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Shahid Beheshti Medical University

Principal Investigators

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Rahman Showkatbakhsh, Professor

Role: STUDY_CHAIR

Shaheed Beheshti dental school

Mohammad Behnaz

Role: PRINCIPAL_INVESTIGATOR

Shahid Beheshti Dental school

Locations

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Shahid Beheshti Medical University

Tehran, , Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Mohammad Behnaz, Orthodontist

Role: CONTACT

09123278021

Facility Contacts

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Mohammad Behnaz

Role: primary

09123278021

Other Identifiers

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behnaz1357

Identifier Type: -

Identifier Source: org_study_id

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