Class II Division 1 Malocclusion Clinical Trial
— FLMGMOfficial title:
A Prospective Controlled Evaluation of Class II Division 1 Malocclusions Treated With Fixed Lingual Mandibular Growth Modificator (FLMGM)
NCT number | NCT01853137 |
Other study ID # | OSAMA-18-2-2013 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2009 |
Est. completion date | December 2012 |
Verified date | October 2020 |
Source | Damascus University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 43 |
Est. completion date | December 2012 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 11 Years to 16 Years |
Eligibility | Inclusion Criteria: Before treatment, each patient fulfilled the following criteria: 1. Cl II/1 malocclusion with an overjet greater than 4 mm. 2. Mild to moderate Class II Skeletal pattern (A-N-B > 4°) with retrognathic mandible (S-N-B < 76°). 3. 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. Exclusion Criteria: - |
Country | Name | City | State |
---|---|---|---|
Syrian Arab Republic | Department of Orthodontics, School of Dentistry, University of Damascus | Damascus |
Lead Sponsor | Collaborator |
---|---|
Damascus University |
Syrian Arab Republic,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Mandibular Length (Co-Gn) | 8 months | ||
Secondary | Overjet Reduction | 8 months |
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