Fixed Lingual Mandibular Growth Modificator
FLMGM
A Prospective Controlled Evaluation of Class II Division 1 Malocclusions Treated With Fixed Lingual Mandibular Growth Modificator (FLMGM)
1 other identifier
interventional
43
1 country
1
Brief Summary
The current trial was designed to investigate the possible initial net skeletal and dental effects of treatment with FLMGM by a comparative evaluation of treated and untreated Cl II/1 malocclusion subjects. The null hypothesis stated that there were no significant differences in dentofacial changes between FLMGM group and control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2009
Longer than P75 for not_applicable
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 10, 2013
CompletedFirst Posted
Study publicly available on registry
May 14, 2013
CompletedResults Posted
Study results publicly available
November 12, 2020
CompletedNovember 12, 2020
October 1, 2020
2.2 years
May 10, 2013
May 14, 2013
October 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Mandibular Length (Co-Gn)
8 months
Secondary Outcomes (1)
Overjet Reduction
8 months
Study Arms (2)
FLMGM Treatment Group
EXPERIMENTALUntreated Class II Control Group
NO INTERVENTIONInterventions
Novel Class II functional appliance, a fixed version of double-plate appliance
Eligibility Criteria
You may qualify if:
- Before treatment, each patient fulfilled the following 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) method28 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 7,29 at the beginning of the treatment/observation period were invited.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Orthodontics, School of Dentistry, University of Damascus
Damascus, Syria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr.
- Organization
- Osama AlAli
Study Officials
- PRINCIPAL INVESTIGATOR
Osama H Alali, PhD
Senior Lecturer, Department of Orthodontics, School of Dentistry, University of Aleppo, Syria
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2013
First Posted
May 14, 2013
Study Start
May 1, 2009
Primary Completion
July 1, 2011
Study Completion
December 1, 2012
Last Updated
November 12, 2020
Results First Posted
November 12, 2020
Record last verified: 2020-10