Thirty-six patients requiring extraction of maxillary first premolars and en-masse retraction of upper anterior teeth will participate in the study. They will be randomly assigned into two groups: low-intensity electrical stimulation group (LIES) and traditional retraction group (TRAD) after the leveling and alignment phase is completed. En-masse retraction will be initiated in both groups via closed nickel-titanium coil springs that applying 250 g of force on each side, Mini-implants will be inserted to provide the highest level of anchorage. The skeletal, dental, and soft tissue changes will be detected using lateral cephalometric radiographs, which will be obtained pretreatment, pre-, and post-en-masse retraction of the anterior teeth.
All candidate patients will be examined to determine the orthodontic treatment plan. Written informed consent will be obtained from all patients who accept to participate in the trial. Self-drilling mini-screws (1.6mm diameter and 8mm length) will be used to provide anchorage. They will be inserted bilaterally 8-10 mm above the level of the interdental papilla, between the second premolars and the first molar. Then, the maxillary first premolar will be extracted. Leveling and alignment of the upper dental arch will be done using a pre-adjusted orthodontic appliance: MBT™, 0.022 × 0.028-inch slots-size brackets. The removable electrical stimulation device utilized in the Shaadouh et al. study to provide the electrical stimulation will be used in this trial for the same purpose. Each patient in the low-intensity electrical stimulation group will be asked to wear a removable device for five hours daily until the completion of the retraction of the upper anterior teeth. The en-masse retraction will be done by applying 250 g force on each side using two NiTi springs attached between the mini-implants and the crimpable hooks in a direction approximately parallel to the occlusal plane. The force will be calibrated every two weeks. The en-masse retraction will continue until a class I canine relationship and a correct incisor relationship, which will consider the endpoint of this phase. Lateral cephalometric radiographs will be obtained pretreatment, pre-, and post-en-masse retraction of the anterior teeth to assess the skeletal, dental, and soft tissue changes. The duration of retraction will be calculated by calculating the time required to achieve complete retraction of the upper anterior teeth through clinical examination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
36
A removable appliance will be used to accelerate orthodontic tooth movement by emitting electrical stimulation.
No additional appliances will be used. Only the traditional fixed appliances (braces).
Department of Orthodontics, Faculty of Dentistry, University of Damascus
Damascus, Syria
Duration of the en-masse retraction of anterior teeth
Assessment will be performed by calculating the time required to achieve complete retraction of the upper anterior teeth (six teeth) through clinical examination.
Time frame: At the end of en-masse retraction which is expected to occur within 6-10 months.
Change in the SNA angle
This angle represents the position of the upper jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
Time frame: The cephalogram will be taken at three times: (T0) before the orthodontic treatment began, (T1) before the en-masse retraction began, (T3) at the end of the en-masse retraction phase (expected to occur within 6-10 months)
Change in the SNB angle
This angle represents the position of the lower jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Time frame: The cephalogram will be taken at three times: (T0) before the orthodontic treatment began, (T1) before the en-masse retraction began, (T3) at the end of the en-masse retraction phase (expected to occur within 6-10 months)
Change in the ANB angle
This angle represents the relationship between the upper and lower jaws in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Time frame: The cephalogram will be taken at three times: (T0) before the orthodontic treatment began, (T1) before the en-masse retraction began, (T3) at the end of the en-masse retraction phase (expected to occur within 6-10 months)
Change in the SNPog angle
This angle represents the position of the chin in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Time frame: The cephalogram will be taken at three times: (T0) before the orthodontic treatment began, (T1) before the en-masse retraction began, (T3) at the end of the en-masse retraction phase (expected to occur within 6-10 months)
Change in the SN-GoMe angle
This angle represents the position of the lower jaw in the cephalometric analysis in the vertical direction. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Time frame: The cephalogram will be taken at three times: (T0) before the orthodontic treatment began, (T1) before the en-masse retraction began, (T3) at the end of the en-masse retraction phase (expected to occur within 6-10 months)
Change in the MM angle
This angle represents the amount of vertical divergence between the upper and lower jaws in the cephalometric analysis. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Time frame: The cephalogram will be taken at three times: (T0) before the orthodontic treatment began, (T1) before the en-masse retraction began, (T3) at the end of the en-masse retraction phase (expected to occur within 6-10 months)
Change in the Bjork's sum
This angle represents the amount of vertical divergence in the cephalometric analysis. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Time frame: The cephalogram will be taken at three times: (T0) before the orthodontic treatment began, (T1) before the en-masse retraction began, (T3) at the end of the en-masse retraction phase (expected to occur within 6-10 months)
Change in Y-axis angle
This angle represents the amount of vertical divergence in the cephalometric analysis. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Time frame: The cephalogram will be taken at three times: (T0) before the orthodontic treatment began, (T1) before the en-masse retraction began, (T3) at the end of the en-masse retraction phase (expected to occur within 6-10 months)
Change in the SN-U1
This angle represents the relationship of the upper anterior teeth with SN in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken, and this angle is going to be measured in degrees
Time frame: The cephalogram will be taken at three times: (T0) before the orthodontic treatment began, (T1) before the en-masse retraction began, (T3) at the end of the en-masse retraction phase (expected to occur within 6-10 months)
Change in the GoMe-L1 angle
This angle represents the relationship of the lower anterior teeth with the mandibular plane in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Time frame: The cephalogram will be taken at three times: (T0) before the orthodontic treatment began, (T1) before the en-masse retraction began, (T3) at the end of the en-masse retraction phase (expected to occur within 6-10 months)
Change in the IIA angle
This angle represents the relationship of the upper and lower anterior teeth in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken, and this angle is going to be measured in degrees.
Time frame: The cephalogram will be taken at three times: (T0) before the orthodontic treatment began, (T1) before the en-masse retraction began, (T3) at the end of the en-masse retraction phase (expected to occur within 6-10 months)
Change in the SV-U1E distance
This measurement represents the distance of the incisal edge of the maxillary incisors from the reference plane SV. Lateral cephalograms will be taken, and this measurement will be in millimeters.
Time frame: The cephalogram will be taken at three times: (T0) before the orthodontic treatment began, (T1) before the en-masse retraction began, (T3) at the end of the en-masse retraction phase (expected to occur within 6-10 months)
Change in the SV-U1A distance
This measurement represents the distance of the apex of the maxillary incisors from the reference plane SV. Lateral cephalograms will be taken, and this measurement will be in millimeters.
Time frame: The cephalogram will be taken at three times: (T0) before the orthodontic treatment began, (T1) before the en-masse retraction began, (T3) at the end of the en-masse retraction phase (expected to occur within 6-10 months)
Change in the Nasolabial angle
This angle represents the relationship of the upper lip with the nose in the cephalometric analysis. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Time frame: The cephalogram will be taken at three times: (T0) before the orthodontic treatment began, (T1) before the en-masse retraction began, (T3) at the end of the en-masse retraction phase (expected to occur within 6-10 months)
Change in the labiomental angle
This angle represents the relationship of the lower lip with the chin in the cephalometric analysis. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Time frame: The cephalogram will be taken at three times: (T0) before the orthodontic treatment began, (T1) before the en-masse retraction began, (T3) at the end of the en-masse retraction phase (expected to occur within 6-10 months)
Change in the UL-E Line distance
This measurement represents the relationship between the upper lip and the Ricketts line in cephalometric analysis. Lateral cephalograms will be taken, and this variable will be measured in mm.
Time frame: The cephalogram will be taken at three times: (T0) before the orthodontic treatment began, (T1) before the en-masse retraction began, (T3) at the end of the en-masse retraction phase (expected to occur within 6-10 months)
Change in the LL-E Line distance
This measurement represents the relationship between the Lower lip and the Ricketts line in cephalometric analysis. Lateral cephalograms will be taken, and this variable will be measured in mm.
Time frame: The cephalogram will be taken at three times: (T0) before the orthodontic treatment began, (T1) before the en-masse retraction began, (T3) at the end of the en-masse retraction phase (expected to occur within 6-10 months)
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