Status:

COMPLETED

Mechanism of Class II Correction With Fixed Lingual Mandibular Growth Modificator (FLMGM)

Lead Sponsor:

Damascus University

Conditions:

Class II Division 1 Malocclusion

Eligibility:

All Genders

11-16 years

Phase:

PHASE2

Brief Summary

The aim of the current controlled trial was to assess the possible net skeletal and dental effects of FLMGM treatment in relation to growth with emphasis on the contribution of skeletal and dental cha...

Detailed Description

The current study was prospective, controlled, parallel groups, clinical trial conducted at the department of Orthodontics between May 2009 and June 2011. The protocol of study was approved by the cou...

Eligibility Criteria

Inclusion

  • Cl II/1 malocclusion with an overjet greater than 4 mm.
  • Mild to moderate Class II Skeletal pattern (A-N-B \> 4°) with retrognathic mandible (S-N-B \< 76°).
  • Growth potential. Fishman skeletal maturation indicator (SMI) method was used to assess the hand-wrist radiographs, and only patients in the peak of the pubertal growth spurt, which occurs on average between SMIs 4 to 7, at the beginning of the treatment/observation period were invited.

Exclusion

  • craniofacial syndromes
  • clinically obvious facial asymmetry
  • extreme vertical disproportion
  • prior orthodontic therapy
  • permanent tooth extractions
  • significant medical history

Key Trial Info

Start Date :

May 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2012

Estimated Enrollment :

43 Patients enrolled

Trial Details

Trial ID

NCT01853995

Start Date

May 1 2009

End Date

December 1 2012

Last Update

April 17 2014

Active Locations (1)

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Department of Orthodontics, School of Dentistry, University of Damascus

Damascus, Rif-dimashq Governorate, Syria