Fixed Lingual Mandibular Growth Modificator
Condition: Class II Division 1 Malocclusion; Retrognathic Mandible
MeSH terms: Malocclusion; Malocclusion, Angle Class II
Study type: Interventional

Summary: 
      The current trial was designed to investigate the possible initial net skeletal and dental
      effects of treatment with FLMGM by a comparative evaluation of treated and untreated Cl II/1
      malocclusion subjects. The null hypothesis stated that there were no significant differences
      in dentofacial changes between FLMGM group and control group.
    

Detailed description: 
      The study was prospective controlled 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.

      The original study sample included 43 patients (25 treated, 18 untreated). Of the 43 patients
      initially enrolled, 38 completed this trial and comprised the final sample, and 5 (4 treated,
      1 untreated) were excluded . 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
      included in the trial regardless of achievement of a Class I incisor relationship. All
      patient of treatment group (n=21) were treated with FLMGM, and 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. Cephalograms
      were digitized on screen and analyzed in a blind manner by the same orthodontist using a
      cephalometric software (Viewbox, 3.1.1.13, Kifissia). . All linear measurements were reduced
      to life size (enlargement: 7.54%).

      Pretreatment equivalence, changes occurring during the examination period in each group and
      comparison of changes observed in both groups were tested for significance with t-tests using
      SPSS . P values of less than 0.05 were considered statistically significant. To assess the
      method error, twenty cephalograms were randomly picked from both groups and redigitized and
      analyzed by the same orthodontist after 1 month, and the method error was calculated by
      Dahlberg's formula.
    

Intervention name(s): Fixed Lingual Mandibular Growth Modificator (FLMGM)
Intervention type(s): Device
Intervention description(s): Novel Class II functional appliance, a fixed version of double-plate appliance
Other intervention name(s): Fixed Lingual Mandibular Growth Modification Appliance (FLMGMA)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Class II division 1 malocclusion; Dentofacial orthopedics; Fixed Lingual Mandibular Growth Modificator (FLMGM)