The Use of Corticotomy for Upper Incisors Retraction
2018年7月27日 更新者：Damascus University
Evaluation of Treatment Outcomes of Corticotomy-accelerated Upper Incisors' Retraction: A Randomized Controlled Trial
We aim to assess the treatment outcomes following upper incisors retraction accelerated by corticotomy procedure.
So, we intend to randomize orthodontic patients with class II division I malocclusion into two groups: experimental group and control group.
Both groups will start orthodontic treatment.
Once a 0.019*0.025-inch
stainless steel wire is fully engaged to the brackets, 1st premolars will be extracted.
Canines will be retracted in the conventional manner.
Then, the actual evaluation period starts when the upper incisors are retracted using two different methods.
研究概览
详细说明
In the last three decades, the number of adult patients seeking short orthodontic treatment time has apparently increased as the conventional orthodontic treatment usually lasts for 20-24 months. Furthermore, orthodontic treatment is often associated with root resorption, bone degradation and caries development. Patients nowadays desire to end the orthodontic treatment as soon as possible due to phsycosocial reasons and to get the goals of the treatment without affecting their social life .
So many tooth movement accelerating methods have been proposed. However, the surgical approached are considered the most effective and promising methods in accelerating tooth movement. The current research aims to evaluate the efficacy of the a new proposed surgical method compared to the conventional method in upper incisors' retraction.
研究类型
介入性
注册 (实际的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Damascus、阿拉伯叙利亚共和国、DM20AM18
- Department of Orthodontics, University of Damascus Dental School
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
15年 至 27年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Adult patients 15 to 27 years , with permanent dentition , without hypodontia .
- Overjet less than 10 mm
- Normal or increased growth pattern (Diagnosed by Y-axis angle)
- Mild to moderate crowding (Less than 3 mm)
- After canines retraction , at least 3 mm space should be available distal the lateral incisors
- Midline deviation shouldn't be more than 3 mm
Exclusion Criteria:
- Medically contraindicated patients to oral surgery .
- Existence of general health issue that affect orthodontic teeth movement
- Previous orthodontic treatment
- Mixed dentition
- Hypodontia (Except third molars)
- Bad oral hygiene
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Corticotomy-assisted Retraction
Corticotomy-assisted retraction will be performed in order to help in accelerating upper incisors' retraction
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Using a tunneling technique, the researcher will perform the intervention in the alveolar bone surrounding the upper incisors before retraction.
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无干预：Conventional Retraction
Conventional retraction will be used in this group of patients by sliding mechanisms
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Rate of retraction
大体时间：This will be measured at the completion of the retraction procedure, and is expected to take 2 months in the experimental group and four months in the control group.
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The distance that the incisors moved during retraction divided by the time required to retract the four upper incisors to their ideal positions.
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This will be measured at the completion of the retraction procedure, and is expected to take 2 months in the experimental group and four months in the control group.
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Time required for retraction
大体时间：This will be measured at the completion of the retraction procedure, and is expected to be within 2 months in the accelerated group and 4 months in the control group.
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The time required from the beginning of incisors' retraction till the the completion of this procedure.
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This will be measured at the completion of the retraction procedure, and is expected to be within 2 months in the accelerated group and 4 months in the control group.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Change in the axial inclination of upper incisors
大体时间：A radiograph will be taken at T1: one day before upper incisors' retraction and T2: one day after the completion of upper incisors' retraction. Completion of upper incisors' retraction is expected to be within 2 months in the accelerated group and 4 mo
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the angle between the long axis of the upper incisor and a reference plane drawn on a later cephalometric radiograph teken at two assessment times.
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A radiograph will be taken at T1: one day before upper incisors' retraction and T2: one day after the completion of upper incisors' retraction. Completion of upper incisors' retraction is expected to be within 2 months in the accelerated group and 4 mo
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Anchorage loss
大体时间：This will be measured one day following the completion of retraction of the upper four incisors using plaster study models and is expected to be within 2 months in the accelerated group and 4 months in the control group
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the amount of anchorage loss (in mm), which is the distance from a perpendicular line to the midpalatal suture and extends between central fossa of both upper first molars to the third palatal rugae .
These measurements are made on plaster study models.
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This will be measured one day following the completion of retraction of the upper four incisors using plaster study models and is expected to be within 2 months in the accelerated group and 4 months in the control group
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Root resorption
大体时间：An panoramic image will be taken at T1: one day before the commencement of incisor retraction and T2: one day following the completion of retraction and is expected to be within 2 months in the accelerated group and 4 months in the control group
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This variable is related to the amount of incisor root resorption after treatment in both groups.
This is measured on a panoramic image.
The amount of root resorption = the length of an incisor after retraction subtracted from the length of an incisor before retraction.
Two radiogrpahs are needed.
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An panoramic image will be taken at T1: one day before the commencement of incisor retraction and T2: one day following the completion of retraction and is expected to be within 2 months in the accelerated group and 4 months in the control group
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Ghaith Al Imam, DDS、MSc student in Orthodontics, University of Damascus Dental School, Damascus, Syria
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Aboul-Ela SM, El-Beialy AR, El-Sayed KM, Selim EM, El-Mangoury NH, Mostafa YA. Miniscrew implant-supported maxillary canine retraction with and without corticotomy-facilitated orthodontics. Am J Orthod Dentofacial Orthop. 2011 Feb;139(2):252-9. doi: 10.1016/j.ajodo.2009.04.028.
- Bhattacharya P, Bhattacharya H, Anjum A, Bhandari R, Agarwal DK, Gupta A, Ansar J. Assessment of Corticotomy Facilitated Tooth Movement and Changes in Alveolar Bone Thickness - A CT Scan Study. J Clin Diagn Res. 2014 Oct;8(10):ZC26-30. doi: 10.7860/JCDR/2014/9448.4954. Epub 2014 Oct 20.
- Al-Naoum F, Hajeer MY, Al-Jundi A. Does alveolar corticotomy accelerate orthodontic tooth movement when retracting upper canines? A split-mouth design randomized controlled trial. J Oral Maxillofac Surg. 2014 Oct;72(10):1880-9. doi: 10.1016/j.joms.2014.05.003. Epub 2014 May 14.
- Choo H, Heo HA, Yoon HJ, Chung KR, Kim SH. Treatment outcome analysis of speedy surgical orthodontics for adults with maxillary protrusion. Am J Orthod Dentofacial Orthop. 2011 Dec;140(6):e251-62. doi: 10.1016/j.ajodo.2011.06.029.
- Chung KR, Kim SH, Lee BS. Speedy surgical-orthodontic treatment with temporary anchorage devices as an alternative to orthognathic surgery. Am J Orthod Dentofacial Orthop. 2009 Jun;135(6):787-98. doi: 10.1016/j.ajodo.2007.03.036.
- Dincer M, Gulsen A, Turk T. The retraction of upper incisors with the PG retraction system. Eur J Orthod. 2000 Feb;22(1):33-41. doi: 10.1093/ejo/22.1.33.
- KOLE H. Surgical operations on the alveolar ridge to correct occlusal abnormalities. Oral Surg Oral Med Oral Pathol. 1959 May;12(5):515-29 concl. doi: 10.1016/0030-4220(59)90153-7. No abstract available.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年8月20日
初级完成 (实际的)
2018年1月20日
研究完成 (实际的)
2018年4月15日
研究注册日期
首次提交
2017年5月9日
首先提交符合 QC 标准的
2017年5月9日
首次发布 (实际的)
2017年5月11日
研究记录更新
最后更新发布 (实际的)
2018年7月30日
上次提交的符合 QC 标准的更新
2018年7月27日
最后验证
2018年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
II 类 1 类咬合不正的临床试验
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University Hospital, Basel, SwitzerlandITI International Team for Implantology, Switzerland招聘中
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Postgraduate Institute of Dental Sciences Rohtak招聘中
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Vastra Gotaland RegionGöteborg University; Region Halland; Västra Götalandsregionen尚未招聘
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Postgraduate Institute of Dental Sciences Rohtak未知Angle Class II, Division 1 Malocclusion印度