CClinicalTrials.gg
CompletedNCT00519415Updated Dec 19, 2008

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

A Phase 3 interventional study of Tongue plate and Facemask in Maxillary Deficiency, sponsored by Shahid Beheshti University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 8 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-12-19.

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

Phase
Phase 3
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
8 Years to 14 Years
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Maxillary Deficiency

Browse trials for

Keywords

  • Tongue plate
  • Facemask
  • class III maxillary deficiency
  • orthodontic angle class three
03

Who can participate

Ages eligible
8 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Growing patients
  • Class III with maxillary deficiency

Exclusion criteria

Exclusion Criteria:

  • Previous orthodontic treatment
  • Un cooperative patients
04

Study design

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

Study arms

  • Experimental
    A

    Other: Tongue plate

  • Experimental
    B

    Other: Facemask

Interventions

  • OtherTongue 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.

    Also known as: tongue appliance

  • OtherFacemask

    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.

    Also known as: Reverse pull headgear

05

What researchers measure

Primary outcomes

  1. Cephalometric angles and clinical features

    Time frame: At least 6 months

06

Study locations

1 site
  • Shaheed Beheshti dental school
    Tehran, Iran, Islamic Republic of
07

Registry details

Key details

Study ID
NCT00519415
Lead sponsor
Shahid Beheshti University of Medical Sciences
First posted
Aug 22, 2007
Start date
Sep 2007
Primary completion
Sep 2008
Completion
Nov 2008
Last update
Dec 19, 2008

Study contacts

Lida Toomarian
study chair · Shaheed Beheshti dental school
Rahman Showkatbakhsh
study director · Shaheed Beheshti dental shool
Mahkameh Mirkarimi
principal investigator · Shaheed Beheshti dental shool

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion