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临床试验/NCT03653078
NCT03653078Unknown不适用

Evaluation of Root Proximity During Mini-Screw Insertion Using a Digital Three-Dimensional Printed Guide Versus Conventional Free Hand Placement Technique in Adult Orthodontic Patients A Split Mouth Randomized Clinical Trial

Cairo University0 个研究点目标入组 30 人开始时间: 2018年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
主要终点
Root proximity

研究概览

简要总结

Although mini screw insertion is considered as a simple and non-invasive technique, it's a critical procedure which requires precision and accuracy. The placement of mini-screw poses a challenge to the orthodontist, particularly if the space available for mini-screws is limited.4 The proximity to the vital structures surrounding the proposed mini-screw position necessitates the precise knowledge of the anatomy of the insertion area.5 The incidence of mini-screw to tooth contact in the placement of inter-radicular region was 27%.6 Although failure of mini screw is considered a multi-factorial concern, many studies reported the proximity of a mini-screw to tooth structures is a major risk factor for failure, especially in the inter-radicular inserted mini-screws. guided insertion was believed to give more favorable results. Above all, the recent technology of the scanning and three-dimensional printing could pave the way to construct a simple accurate guide. Additionally all previous studies assessed the insertion accuracy using CBCT post-operatively, that can't be applied on human subjects for ethical reasons. Thus a non-invasive method for assessment of mini-screw insertion should be implemented.

详细描述

PICOs P: Adult orthodontic patients need mini screws in maxillary arch bilaterally for anchorage I: Three dimensional printed digital guide for mini screw insertion C: Conventional free hand insertion technique

  • O: Primary outcome: Root proximity

Secondary outcomes:

  • Patient discomfort during insertion 17
  • Insertion accuracy
  • Angular deviation
  • Linear deviation
  • Failure 18 S: Split Mouth Randomized clinical Trial

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
Double (Participant, Outcomes Assessor)

盲法说明

during the insertion procedure the principle investigator and the co supervisor couldn't be blinded, as the two insertion techniques are completely different.

入排标准

年龄范围
14 Years 至 45 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Orthodontic patients with Angle's Class I bimaxillary protrusion • Patients having average mandibular plane angle

排除标准

  • •Mixed dentition patients
  • •Smoker patients
  • •Patients with Increased lower facial height
  • •Patients with missing posterior teeth
  • •Bleeding disorders or anticoagulant therapy
  • •Patients with cleft lip & palate
  • •Patients with facial asymmetry
  • •Patients with transverse maxillary deficiency

研究组 & 干预措施

Three dimensional printed digital guide

Experimental

one mini-screw will be inserted in the buccal interradicular space between upper second premolar and first molar using Three dimensional printed digital guide, which is a device deisgned and printed through CAD/CAM technology, it's a printed plate fit on the teeth and buccal mucosa with a channel for mini- screw insertion, mini-screw will be inserted through the plate's channel

干预措施: Three dimensional printed digital guide (Device)

Conventional free hand insertion

No Intervention

one mini-screw will be inserted in the buccal interradicular space between upper second premolar and first molar using conventional free hand insertion of mini-screw, which is a technique using the guiding anatomy for mini-screw insertion using the driver and the operator's skill.

结局指标

主要结局

Root proximity

时间窗: immediately after mini-screw insertion (T0)

Distance between inserted mini screw and the adjacent roots in microns

次要结局

  • Patient discomfort:(immediately after mini-screw insertion (T0))

研究者

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

Hadir Aboshady

Principle investigator

Cairo University

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