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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01853995
Recruitment Status : Completed
First Posted : May 15, 2013
Last Update Posted : April 17, 2014
Information provided by (Responsible Party):
Osama AlAli, Damascus University

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 changes to sagittal correction of Cl II/1 malocclusion.

The null hypothesis stated that there were no significant differences in dentoskeletal changes between FLMGM treated group and control untreated group.

Condition or disease Intervention/treatment Phase
Class II Division 1 Malocclusion Device: Fixed Lingual Mandibular Growth Modificator (FLMGM) Phase 2

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 council of scientific research and postgraduate studies, on the 5/April/2009.

Of the 43 patients initially enrolled, 38 completed this trial and comprised the final sample, and 5 (4 treated, 1 untreated) were excluded.

The final sample comprised 38 subjects who completed this trial. All patients and parents gave prior informed consent to their inclusion in the investigation.

Patients of both groups were followed on a parallel basis during a period of 8 months and the trial included all patients regardless of achievement of a Class I incisor relationship. All patient of treatment group (n=21) were treated using FLMGM without extractions or any other form of orthodontic treatment, though the treatment was continued beyond this time point if the Class II malocclusion was not fully corrected and clinical objectives were not achieved. On the other hand, no orthodontic treatment was performed during that duration for the subjects of control group (n=17), and most of control subjects were offered suitable treatment at a later date.

For each patient, a direct digital lateral cephalogram was taken pre- and post- treatment/observation using PAX 400 (VATECH CO., Korea) with the same settings. All cephalograms were digitized on screen by a cursor-driven mouse and analyzed in a blind manner by the same orthodontist using a commercial cephalometric software (Viewbox, version, dHAL Software, Kifissia , Hellas, Greece). All measurements were reduced to life size (radiographic enlargement of 7.54 % in the median plane).

At the end of the treatment/observation period, sagittal occlusal (SO) analysis, according to the method of Pancherz modified by Franchi et al, was applied to assess sagittal occlusal changes and identify the mechanism of Class II correction. Moreover, the total mandibular length (Condyle-Gnathion) was measured.

The sample was used as a whole and not differentiated by sex. Pretreatment equivalence and comparison of changes observed in the FLMGM and control groups were tested for significance with independent-sample t-test using SPSS, version 16.0. Changes occurring during the examination period in each group were tested with paired-sample t-test. P values of less than 0.05 were considered statistically significant.

To assess the method error, twenty cephalograms were picked at random from the treatment and control groups and redigitized and analyzed by the same orthodontist after an interval of 1 month, and the combined error of cephalometric method was calculated by Dahlberg's formula.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Class II Division 1 Malocclusions Treated With Fixed Lingual Mandibular Growth Modificator (FLMGM): The Mechanism of Sagittal Occlusal Correction
Study Start Date : May 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: FLMGM Treatment Group
Cl II/1 patients treated with Fixed Lingual Mandibular Growth Modificator (FLMGM)
Device: Fixed Lingual Mandibular Growth Modificator (FLMGM)
New Class II Corrector
Other Name: Fixed Lingual Mandibular Growth Modification Appliance

No Intervention: Untreated Class II Control Group
control group

Primary Outcome Measures :
  1. Overjet reduction and Class II molar correction [ Time Frame: 8 months ]

Secondary Outcome Measures :
  1. Total mandibular length (Co-Gn) [ Time Frame: 8 months ]

Other Outcome Measures:
  1. Standard Dental and skeletal changes [ Time Frame: 8 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01853995

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Syrian Arab Republic
Department of Orthodontics, School of Dentistry, University of Damascus
Damascus, Syrian Arab Republic
Sponsors and Collaborators
Damascus University
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Principal Investigator: Osama H Alali, PhD Senior Lecturer, Department of Orthodontics, School of Dentistry, University of Aleppo, Syria
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Responsible Party: Osama AlAli, Dr., Damascus University Identifier: NCT01853995    
Other Study ID Numbers: FLMGM: Mechanism of Correction
First Posted: May 15, 2013    Key Record Dates
Last Update Posted: April 17, 2014
Last Verified: March 2014
Keywords provided by Osama AlAli, Damascus University:
Fixed Lingual Mandibular Growth Modificator (FLMGM)
Class II division 1 malocclusion
Sagittal Occlusal Correction
Skeletal changes
Dental changes
Additional relevant MeSH terms:
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Malocclusion, Angle Class II
Tooth Diseases
Stomatognathic Diseases