ClinicalTrials.gg
Status unknownNCT00916084Updated Jul 27, 2010

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

A Phase 3 interventional study of Fixed Tongue Appliance and Fixed Face Mask in Maxillary Deficiency, sponsored by Shahid Beheshti University. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 7 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-07-27.

Sponsored by Shahid Beheshti University · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
7 Years to 11 Years
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Maxillary Deficiency

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03

In context

Retrognathia

62 studies on the registry are indexed under Retrognathia; 15 are open to participants now.

This study's planned enrollment of 20 is below the median of 34 across 52 interventional studies indexed under Retrognathia.

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Lead sponsor

Shahid Beheshti University is the lead sponsor of 37 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Growing patients
  • Class III with maxillary deficiency

Exclusion criteria

Exclusion Criteria:

  • Previous orthodontic treatment
  • Uncooperative patients
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Group A

    Device: Fixed Tongue Appliance

  • Experimental
    Group B

    Device: Fixed Face Mask

Interventions

  • DeviceFixed 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.

    Also known as: tongue plate

  • DeviceFixed 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.

    Also known as: face mask

06

What researchers measure

Primary outcomes

  1. Cephalometric angles and clinical features

    Time frame: At least 6 months

07

Study locations

1 of 1 sites recruiting
  • Shahid Beheshti Medical University
    Tehran, Iran, Islamic Republic of
    Recruiting
    • Mohammad Behnaz · ContactBehnaz1357@yahoo.com · 09123278021
    • Mohammad Behnaz, Orthodontist · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2009, a primary completion of Apr 2010 and a completion of Aug 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 8, 2009
First posted
Jun 9, 2009
Start
Jun 2009
Primary completionEst.
Apr 2010
CompletionEst.
Aug 2010
Last update
Jul 27, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 27, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00916084
Lead sponsor
Shahid Beheshti University
First posted
Jun 9, 2009
Start date
Jun 2009
Primary completion
Apr 2010 (estimated)
Completion
Aug 2010 (estimated)
Last update
Jul 27, 2010

Study contacts

Mohammad Behnaz, Orthodontist
Contact
behnaz1357@yahoo.com
09123278021
Rahman Showkatbakhsh, Professor
study chair · Shaheed Beheshti dental school
Mohammad Behnaz
principal investigator · Shahid Beheshti Dental school

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.

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