NCT00519415

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2007

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

December 19, 2008

Status Verified

December 1, 2008

Enrollment Period

1 year

First QC Date

August 20, 2007

Last Update Submit

December 18, 2008

Conditions

Maxillary Deficiency

Keywords

Tongue plateFacemaskclass III maxillary deficiencyorthodontic angle class three

Outcome Measures

Primary Outcomes (1)

  • Cephalometric angles and clinical features

    At least 6 months

Study Arms (2)

A

EXPERIMENTAL
Other: Tongue plate

B

EXPERIMENTAL
Other: Facemask

Interventions

Tongue plateOTHER

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
A
FacemaskOTHER

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
B

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Growing patients
  • Class III with maxillary deficiency

You may not qualify if:

  • Previous orthodontic treatment
  • Un cooperative patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaheed Beheshti dental school

Tehran, Iran

Location

MeSH Terms

Conditions

Retrognathia

Condition Hierarchy (Ancestors)

Jaw AbnormalitiesJaw DiseasesMusculoskeletal DiseasesMaxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesStomatognathic DiseasesMandibular DiseasesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Lida Toomarian

    Shaheed Beheshti dental school

    STUDY CHAIR

  • Rahman Showkatbakhsh

    Shaheed Beheshti dental shool

    STUDY DIRECTOR

  • Mahkameh Mirkarimi

    Shaheed Beheshti dental shool

    PRINCIPAL INVESTIGATOR

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

August 20, 2007

First Posted

August 22, 2007

Study Start

September 1, 2007

Primary Completion

September 1, 2008

Study Completion

November 1, 2008

Last Updated

December 19, 2008

Record last verified: 2008-12

Locations

IR(1)