Fixed Lingual Mandibular Growth Modificator (FLMGM)
|ClinicalTrials.gov Identifier: NCT01853137|
Recruitment Status : Completed
First Posted : May 14, 2013
Last Update Posted : May 14, 2013
|Condition or disease||Intervention/treatment||Phase|
|Class II Division 1 Malocclusion Retrognathic Mandible||Device: Fixed Lingual Mandibular Growth Modificator (FLMGM)||Phase 2|
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, 188.8.131.52, 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Controlled Evaluation of Class II Division 1 Malocclusions Treated With Fixed Lingual Mandibular Growth Modificator (FLMGM)|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||December 2012|
|Experimental: FLMGM Treatment Group||
Device: Fixed Lingual Mandibular Growth Modificator (FLMGM)
Novel Class II functional appliance, a fixed version of double-plate appliance
Other Name: Fixed Lingual Mandibular Growth Modification Appliance (FLMGMA)
|No Intervention: Untreated Class II Control Group|
- Total mandibular length (Co-Gn) [ Time Frame: 8 months ]
- Overjet reduction [ Time Frame: 8 months ]
- Standard skeletal and dental cephalometric variable [ Time Frame: 8 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853137
|Syrian Arab Republic|
|Department of Orthodontics, School of Dentistry, University of Damascus|
|Damascus, Syrian Arab Republic|
|Principal Investigator:||Osama H Alali, PhD||Assistant Professor, Department of Orthodontics, School of Dentistry, University of Damascus, Syria|