Class II Division 1 Malocclusion, Retrognathic Mandible
Conditions
Keywords
Class II division 1 malocclusion, Dentofacial orthopedics, Fixed Lingual Mandibular Growth Modificator (FLMGM)
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.
Detailed description
The study was prospective controlled 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. 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.
Interventions
Novel Class II functional appliance, a fixed version of double-plate appliance
Sponsors
Damascus University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to 16 Years
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Mandibular Length (Co-Gn) | 8 months |
Secondary
| Measure | Time frame |
|---|---|
| Overjet Reduction | 8 months |
Countries
Syria
Participant flow
Recruitment details
patients were recruited from those referred to the department of Orthodontics at the University of Damascus between May 2009 and June 2011.
Participants by arm
| Arm | Count |
|---|---|
| FLMGM Treatment Group Fixed Lingual Mandibular Growth Modificator (FLMGM) : Novel Class II functional appliance, a fixed version of double-plate appliance | 25 |
| Untreated Class II Control Group | 18 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 1 |
Baseline characteristics
| Characteristic | Total | FLMGM Treatment Group | Untreated Class II Control Group |
|---|---|---|---|
| Age, Categorical <=18 years | 43 Participants | 25 Participants | 18 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 13.0 years STANDARD_DEVIATION 1.3 | 13.2 years STANDARD_DEVIATION 0.9 | 12.5 years STANDARD_DEVIATION 2.1 |
| Region of Enrollment Syrian Arab Republic | 43 participants | 25 participants | 18 participants |
| Sex: Female, Male Female | 24 Participants | 14 Participants | 10 Participants |
| Sex: Female, Male Male | 19 Participants | 11 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 17 |
| serious Total, serious adverse events | 0 / 21 | 0 / 17 |
Outcome results
Primary
Total Mandibular Length (Co-Gn)
Time frame: 8 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FLMGM Treatment Group | Total Mandibular Length (Co-Gn) | 3.51 mm | Standard Deviation 1.37 |
| Untreated Class II Control Group | Total Mandibular Length (Co-Gn) | 1.18 mm | Standard Deviation 1.13 |
Secondary
Overjet Reduction
Time frame: 8 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FLMGM Treatment Group | Overjet Reduction | -3.32 mm | Standard Deviation 2.86 |
| Untreated Class II Control Group | Overjet Reduction | 0.74 mm | Standard Deviation 0.94 |