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临床试验/NCT04202016
NCT04202016已完成不适用

Three Dimensional Analysis of the Rate of Space Closure With Piezocision-based Corticotomy in Different Facial Types: A Split-mouth Design Randomized Controlled Trial

Jordan University of Science and Technology2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
2
主要终点
Rate of space closure

研究概览

简要总结

23 female participants with class II div I will have extraction of bilateral first bicuspids 10 weeks after bond- up appointment. The extracted teeth will be preserved in special containers for subsequent microscopic analysis. Four months later, upon space closure phase, the patient will have a piezocision surgery on one side randomly chosen. Virtual models will be generated once before the surgery and monthly after for four and a half months. The models will be scanned by CADCAM and later tooth movement will be analyzed in regards to the rugae area.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

A third party will have the randomization of which side to be chosen for each case. An IT student will be asked to prepare randomized two lists using excel Microsoft program. Each list was defined based on facial divergence type; adult high, and adult average lists in the Excel columns. Underneath each list, the raws, equal number of R(right) and L(left) letters will be generated randomly. The orthodontic department's receptionist will receive the excel file, and based on which, prepare closed envelops that will be numbered. Each of which will contain a piece of paper having a letter, either R or L accordingly. The envelops will be dark and difficult to see through even under light. The periodontist will open the envelope of each patient only prior to their piezocision surgery without the involvement of the orthodontist.

入排标准

年龄范围
15 Years 至 29 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Young adults and adults (15-29).
  • Middleastern Caucasian.
  • Having the defined orthodontic appliance, slot size, prescription, and technique of space closure.
  • Class II division I of moderate space requirement that is planned to have the first premolar extracted.
  • Average or high facial type.
  • Healthy patients without systematic diseases that could affect bone and tooth movement and no contraindication (medical or psychological) to avoid oral surgery.
  • No active periodontal diseases as this effect the cytokines expression (stabilized prostaglandin (PG) health)
  • Good oral hygiene.
  • No other method of non-surgical acceleration technique to be used.

排除标准

  • Patients who refused to consent for the study.
  • The two extremes of age (younger than 14 and older than 29).
  • Having other than the defined orthodontic appliance, slot size, prescription, and technique of space closure.
  • Extraction cases of high space requirements or other teeth than the first premolar.
  • Patients with systematic diseases that could affect bone and tooth movement and no contraindication (medical or psychological) avoid oral surgery.
  • Active periodontal diseases.
  • Other methods of non-surgical acceleration technique to be used.

结局指标

主要结局

Rate of space closure

时间窗: four and half months

Every six weeks from the first impression, made on the day of surgery (T0), an impression will be taken, (T1, T2, T3). Images of the impressions will be generated using computer-aided design and computer-aided manufacturing (CADCAM) to evaluate the space changes from a fixed reference point; the rugae area.

次要结局

  • Root resorption(Ten weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hadeel alaathal

Principal Investigator

Jordan University of Science and Technology

研究点 (2)

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