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临床试验/NCT06293872
NCT06293872已完成不适用

Evaluation of Two Mini-Implant Lengths in the Infra-Zygomatic Crest Region (A Randomized Clinical Trial, Split-mouth Study)

University of Baghdad2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年2月25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
24
试验地点
2
主要终点
failure rate

研究概览

简要总结

Evaluation of two different lengths of mini-implants in the infrazygomatic area regarding primary stability, pain perception, sinus penetration, secondary stability and failure rate.

详细描述

orthodontic mini-implants, also known as miniscrew, implants or temporary anchorage devices, offer an effective panacea for Anchorage loss problem during fixed appliance treatments.

Indeed, Mini-implant implantation has become an essential method of controlling anchorage in the clinic and plays an important role in solving some difficult cases, where the integration of orthodontic mini-implants within fixed appliance treatments offers other advantages over conventional anchorage.

Intra-radicular micro-implants are placed in between the roots of teeth (mostly) while extra-radicular bone screws are placed away from the roots in the infra-zygomatic areas (IZC) of the maxilla and the buccal shelf areas (BS) of the mandible. Both extra-radicular bone screws and intra-radicular are classified under temporary anchorage devices used for the purpose of skeletal anchorage.

Due to the limited space, there is a risk of injury to the roots while using Intra-radicular micro-implants. Therefore, the infrazygomatic crest zone is selected as an alternative implantation site in the clinic. The infrazygomatic crest has a double-layered cortex and is close to the maxillary center of the resistance, which is suitable for implantation and provides strong anchorage.

Orthodontic bone screws can be used in almost every clinical situation that a micro-implant is used for, except that they cannot be placed inter-dental purely because of their larger dimension. They can be used for molar uprighting, segmental, and full arch distalization, intrusion of single tooth to full arch, protraction and retraction of dentition and for any other anchorage needs.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
15 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • a. Patients (age of patients is 15-50 y.) need metal fixed orthodontic treatment including placement of miniscrews.
  • b. The position of mini-implant in upper buccal posterior area (infrazygomatic area).

排除标准

  • • If c.b.c.t show that the screw placed intraradicular will be excluded.
  • Patient choose to discontinue the treatment was regarded as dropout, since this study pre protocol analysis. exclusion criteria, such as images suggesting
  • Images suggesting sinus inflammation or pathology before mini-implant insertin.

结局指标

主要结局

failure rate

时间窗: 6 months

the miniscrew regarded as failed if it is mobile and can not fulfill it is anchorage function, covered by soft tissue.

次要结局

  • primary stability(immediately after placement)
  • secondary stability(after 6months)
  • pain perception(after 1st day and after 1st week)

研究者

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

Abbas Fadhil Alsaeedi

Bachelor's dental Surgery ( B. D. S)

University of Baghdad

研究点 (2)

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