Mechanism of Class II Correction With Fixed Lingual Mandibular Growth Modificator (FLMGM) (FLMGM)
|ClinicalTrials.gov Identifier: NCT01853995|
Recruitment Status : Completed
First Posted : May 15, 2013
Last Update Posted : April 17, 2014
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|
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 18.104.22.168, 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- Overjet reduction and Class II molar correction [ Time Frame: 8 months ]
- Total mandibular length (Co-Gn) [ Time Frame: 8 months ]
- Standard Dental and skeletal changes [ Time Frame: 8 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853995
|Syrian Arab Republic|
|Department of Orthodontics, School of Dentistry, University of Damascus|
|Damascus, Syrian Arab Republic|
|Principal Investigator:||Osama H Alali, PhD||Senior Lecturer, Department of Orthodontics, School of Dentistry, University of Aleppo, Syria|