Mechanism of Class II Correction With Fixed Lingual Mandibular Growth Modificator (FLMGM) (FLMGM)
Primary Purpose
Class II Division 1 Malocclusion
Status
Completed
Phase
Phase 2
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Fixed Lingual Mandibular Growth Modificator (FLMGM)
Sponsored by
About this trial
This is an interventional treatment trial for Class II Division 1 Malocclusion focused on measuring Fixed Lingual Mandibular Growth Modificator (FLMGM), Class II division 1 malocclusion, Sagittal Occlusal Correction, Skeletal changes, Dental changes
Eligibility Criteria
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
Sites / Locations
- Department of Orthodontics, School of Dentistry, University of Damascus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
FLMGM Treatment Group
Untreated Class II Control Group
Arm Description
Cl II/1 patients treated with Fixed Lingual Mandibular Growth Modificator (FLMGM)
control group
Outcomes
Primary Outcome Measures
Overjet reduction and Class II molar correction
Secondary Outcome Measures
Total mandibular length (Co-Gn)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01853995
Brief Title
Mechanism of Class II Correction With Fixed Lingual Mandibular Growth Modificator (FLMGM)
Acronym
FLMGM
Official Title
Class II Division 1 Malocclusions Treated With Fixed Lingual Mandibular Growth Modificator (FLMGM): The Mechanism of Sagittal Occlusal Correction
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Damascus University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Division 1 Malocclusion
Keywords
Fixed Lingual Mandibular Growth Modificator (FLMGM), Class II division 1 malocclusion, Sagittal Occlusal Correction, Skeletal changes, Dental changes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FLMGM Treatment Group
Arm Type
Experimental
Arm Description
Cl II/1 patients treated with Fixed Lingual Mandibular Growth Modificator (FLMGM)
Arm Title
Untreated Class II Control Group
Arm Type
No Intervention
Arm Description
control group
Intervention Type
Device
Intervention Name(s)
Fixed Lingual Mandibular Growth Modificator (FLMGM)
Other Intervention Name(s)
Fixed Lingual Mandibular Growth Modification Appliance
Intervention Description
New Class II Corrector
Primary Outcome Measure Information:
Title
Overjet reduction and Class II molar correction
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Total mandibular length (Co-Gn)
Time Frame
8 months
Other Pre-specified Outcome Measures:
Title
Standard Dental and skeletal changes
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osama H Alali, PhD
Organizational Affiliation
Senior Lecturer, Department of Orthodontics, School of Dentistry, University of Aleppo, Syria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Orthodontics, School of Dentistry, University of Damascus
City
Damascus
Country
Syrian Arab Republic
12. IPD Sharing Statement
Learn more about this trial
Mechanism of Class II Correction With Fixed Lingual Mandibular Growth Modificator (FLMGM)
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