Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
43 participants
INTERVENTIONAL
2009-05-31
2012-12-31
Brief Summary
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Detailed Description
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The original study sample included 43 patients (25 treated, 18 untreated). Of the 43 patients initially enrolled, 38 completed this trial and comprised the final sample, and 5 (4 treated, 1 untreated) were excluded . 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 included in the trial regardless of achievement of a Class I incisor relationship. All patient of treatment group (n=21) were treated with FLMGM, and 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. Cephalograms were digitized on screen and analyzed in a blind manner by the same orthodontist using a cephalometric software (Viewbox, 3.1.1.13, Kifissia). . All linear measurements were reduced to life size (enlargement: 7.54%).
Pretreatment equivalence, changes occurring during the examination period in each group and comparison of changes observed in both groups were tested for significance with t-tests using SPSS . P values of less than 0.05 were considered statistically significant. To assess the method error, twenty cephalograms were randomly picked from both groups and redigitized and analyzed by the same orthodontist after 1 month, and the method error was calculated by Dahlberg's formula.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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FLMGM Treatment Group
Fixed Lingual Mandibular Growth Modificator (FLMGM)
Novel Class II functional appliance, a fixed version of double-plate appliance
Untreated Class II Control Group
No interventions assigned to this group
Interventions
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Fixed Lingual Mandibular Growth Modificator (FLMGM)
Novel Class II functional appliance, a fixed version of double-plate appliance
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
11 Years
16 Years
ALL
No
Sponsors
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Damascus University
OTHER
Responsible Party
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Principal Investigators
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Osama H Alali, PhD
Role: PRINCIPAL_INVESTIGATOR
Senior Lecturer, Department of Orthodontics, School of Dentistry, University of Aleppo, Syria
Locations
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Department of Orthodontics, School of Dentistry, University of Damascus
Damascus, , Syria
Countries
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Other Identifiers
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OSAMA-18-2-2013
Identifier Type: -
Identifier Source: org_study_id