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

Class II Division 1 Malocclusion Clinical Trial

— FLMGM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01853995
• Other study ID #: FLMGM: Mechanism of Correction
• Status: Completed
• Phase: Phase 2
• First received: May 13, 2013
• Last updated: March 21, 2014
• Start date: May 2009
• Est. completion date: December 2012

Study information

• Verified date: March 2014
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 16 Years

Eligibility

Inclusion Criteria:

• Cl II/1 malocclusion with an overjet greater than 4 mm.

• Mild to moderate Class II Skeletal pattern (A-N-B > 4°) with retrognathic mandible (S-N-B < 76°).

• Growth potential. Fishman skeletal maturation indicator (SMI) method was used to assess the hand-wrist radiographs, and only patients in the peak of the pubertal growth spurt, which occurs on average between SMIs 4 to 7, at the beginning of the treatment/observation period were invited.

Exclusion Criteria:

• craniofacial syndromes

• clinically obvious facial asymmetry

• extreme vertical disproportion

• prior orthodontic therapy

• permanent tooth extractions

• significant medical history

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Class II Division 1 Malocclusion
• Malocclusion

Intervention

Device:
• Fixed Lingual Mandibular Growth Modificator (FLMGM)
New Class II Corrector

Locations

Country	Name	City	State
Syrian Arab Republic	Department of Orthodontics, School of Dentistry, University of Damascus	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Standard Dental and skeletal changes		8 months	No
Primary	Overjet reduction and Class II molar correction		8 months	No
Secondary	Total mandibular length (Co-Gn)		8 months	No