Mechanism of Class II Correction With Fixed Lingual Mandibular Growth Modificator (FLMGM)
Condition: Class II Division 1 Malocclusion
MeSH terms: Malocclusion; Malocclusion, Angle Class II
Study type: Interventional
Phase: Phase 2

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.
    

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
      3.1.1.13, 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.
    

Intervention name(s): Fixed Lingual Mandibular Growth Modificator (FLMGM)
Intervention type(s): Device
Intervention description(s): New Class II Corrector
Other intervention name(s): Fixed Lingual Mandibular Growth Modification Appliance
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fixed Lingual Mandibular Growth Modificator (FLMGM); Class II division 1 malocclusion; Sagittal Occlusal Correction; Skeletal changes; Dental changes