Comparative Results of Maxillary Deficiency Treatment by Fixed Tongue Appliance and Fixed Facemask in Growing Patients
This Study is to Apply the Tongue Force to Correct the Dentofacial Deformities
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2009
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 8, 2009
CompletedFirst Posted
Study publicly available on registry
June 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedJuly 27, 2010
December 1, 2009
10 months
June 8, 2009
July 26, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Cephalometric angles and clinical features
At least 6 months
Study Arms (2)
Group A
EXPERIMENTALGroup B
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- Growing patients
- Class III with maxillary deficiency
You may not qualify if:
- Previous orthodontic treatment
- Uncooperative patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shahid Beheshti Medical University
Tehran, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Rahman Showkatbakhsh, Professor
Shaheed Beheshti dental school
- PRINCIPAL INVESTIGATOR
Mohammad Behnaz
Shahid Beheshti Dental school
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 8, 2009
First Posted
June 9, 2009
Study Start
June 1, 2009
Primary Completion
April 1, 2010
Study Completion
August 1, 2010
Last Updated
July 27, 2010
Record last verified: 2009-12