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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Class II Division 1 Malocclusions Treated With Fixed Lingual Mandibular Growth Modificator (FLMGM): The Mechanism of Sagittal Occlusal Correction

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.

Detailed Summary:

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).

Same as current

Information By: Damascus University

Dates:
Date Received: May 13, 2013
Date Started: May 2009
Date Completion:
Last Updated: March 21, 2014
Last Verified: March 2014