Evaluation the Effect of Low-intensity Electrical Current (LIEC) in Accelerating the En-masse Retraction of the Maxillary Anterior Teeth and the Associated Skeletal, Dental and Periodontal Changes : A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Duration of en-masse retraction of anterior teeth
研究概览
简要总结
Thirty two patients requiring extraction of maxillary first premolars and en-masse retraction of upper anterior teeth will participate in the study. They will be divided randomly into two groups: electrical group and control group. In each group, en-masse retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 250 g of force per side, Mini-implants will be used as an anchor unit.
The overall retraction duration will be calculated. The skeletal, dental and soft tissue changes will be detected using panoramic and lateral cephalometric radiographs which will be obtained pretreatment, pre and post en-masse retraction of the anterior teeth.
详细描述
Prior to enrollment of each subject into the study, they will be examined completely to determine the orthodontic treatment plan. The operator will inform them about the aim of the study and ask them to provide a written informed consent.
Self-drilling titanium mini-implants (1.6mm diameter and 8mm length) will be used. They will be inserted between the maxillary second premolar and first molar at approximately 8-10 mm above the archwires at the mucogingival junction and will be checked for primary stability (mechanical retention). Then the maxillary first premolar will be extracted. The maxillary arch will be levelled and aligned. The rectangular stainless steel archwires (0.019" × 0.025") with anterior 8mm height soldered hooks distal to the canines will be inserted.
A removable device containing a small electrical circuit will be applied to each patient to supply the required electric current.
Each patient in the electrical group will be asked to wear a removable device containing a small electrical circuit that will supply the required electric current for five hours a day until the completion the retraction of the upper anterior teeth.
(250-300) g force will be applied on each side using two NiTi springs attached between the mini-implants and the soldered hooks in a direction approximately parallel to the occlusal plane for conducting an en-masse retraction. The force level will be measured every 2 weeks. Retraction will be stopped when a class I canine relationship will be achieved and a good incisor relationship will be obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult healthy patients, Male and female, Age range: 15-27 years.
- •Class II Division 1 malocclusion :
- •Mild / moderate skeletal Class II (sagittal discrepancy angle ≤7)
- •Overjet ≤10
- •Normal or excessive facial height (Clinically and then cephalometrically assessed using these three angles : mandibular/cranial base angle, maxillary/mandibular plane angle and facial axis angle)
- •Mild to moderate crowding ≤ 4
- •Permanent occlusion.
- •Existence of all the upper teeth (except third molars).
- •Good oral and periodontal health:
- •Probing depth < 4 mm
- •No radiographic evidence of bone loss.
- •Gingival index ≤ 1
- •Plaque index ≤ 1
排除标准
- •Medical problems that affect tooth movement (corticosteroid, nonsteroidal anti-inflammatory drugs (NSAIDs), ...)
- •Presence of primary teeth in the maxillary arch
- •Missing permanent maxillary teeth (except third molars).
- •Poor oral hygiene or Current periodontal disease:
- •Probing depth ≥ 4 mm
- •radiographic evidence of bone loss
- •Gingival index > 1
- •Plaque index > 1
- •Patient had previous orthodontic treatment
研究组 & 干预措施
electric current
Electric current will be applied in this group of patients using removable device.
干预措施: Low-intensity electrical current (LIEC) (Device)
Traditional treatment
No acceleration method will be performed in this group.
干预措施: Traditional fixed orthodontic appliance (Device)
结局指标
主要结局
Duration of en-masse retraction of anterior teeth
时间窗: The months required to complete the retraction procedure will be recorded. Completion of this procedure is expected to be occur within six months in the experimental group and eight months in the control group.
Assessment will be performed by calculating the time required to achieve complete retraction of the upper anterior teeth (six teeth) through clinical examination.
Change in the SN-U1 angle
时间窗: : The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.
This angle the 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.
Change in the SNA angle
时间窗: : The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.
This angle the 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.
Change in the MM angle
时间窗: : The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.
This angle the represents the amount of vertical divergence between the upper and lower jaws in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
次要结局
- Change in the Nasolabial angle(: The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.)
- Change in the Li-E Line(: The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.)
- Change in Root Length(This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.)
- Change in the Plaque index(This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.)
- Change in the Gingival Index(This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.)
- Change in the Bleeding Index(This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.)
- Change in the Probing Depth(Two measurements are required for this calculation: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.)
- Change in the Gingival Recession(Two measurements are required for this calculation: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.)