Mechanism of Class II Correction With Fixed Lingual Mandibular Growth Modificator (FLMGM)
FLMGM
Class II Division 1 Malocclusions Treated With Fixed Lingual Mandibular Growth Modificator (FLMGM): The Mechanism of Sagittal Occlusal Correction
1 other identifier
interventional
43
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2009
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 13, 2013
CompletedFirst Posted
Study publicly available on registry
May 15, 2013
CompletedApril 17, 2014
March 1, 2014
2.2 years
May 13, 2013
March 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overjet reduction and Class II molar correction
8 months
Secondary Outcomes (1)
Total mandibular length (Co-Gn)
8 months
Other Outcomes (1)
Standard Dental and skeletal changes
8 months
Study Arms (2)
FLMGM Treatment Group
EXPERIMENTALCl II/1 patients treated with Fixed Lingual Mandibular Growth Modificator (FLMGM)
Untreated Class II Control Group
NO INTERVENTIONcontrol group
Interventions
New Class II Corrector
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- craniofacial syndromes
- clinically obvious facial asymmetry
- extreme vertical disproportion
- prior orthodontic therapy
- permanent tooth extractions
- significant medical history
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Orthodontics, School of Dentistry, University of Damascus
Damascus, Rif-dimashq Governorate, Syria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Osama H Alali, PhD
Senior Lecturer, Department of Orthodontics, School of Dentistry, University of Aleppo, Syria
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
May 13, 2013
First Posted
May 15, 2013
Study Start
May 1, 2009
Primary Completion
July 1, 2011
Study Completion
December 1, 2012
Last Updated
April 17, 2014
Record last verified: 2014-03