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临床试验/NCT07661277
NCT07661277Enrolling By Invitation不适用

Factors Associated With the Failure Rate of Infra-Zygomatic Orthodontic Mini-Screws

Tanzila Rafique1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
30
试验地点
1

研究概览

简要总结

The goal of this randomized clinical study is to assess the factors associated with the failure rate of infra-zygomatic crest orthodontic mini-screws used for anchorage reinforcement during orthodontic treatment.

详细描述

Researchers will evaluate the influence of mini-screw length, diameter, oral hygiene status, age, sex, and loading time on the failure rate of infra-zygomatic mini-screws. Mini-screw failure will be assessed clinically by the presence of mobility or loss of stability.

Participants will:

  • Receive fixed orthodontic treatment with a pre-adjusted edgewise appliance system.
  • Receive infra-zygomatic mini-screws bilaterally for maxillary anchorage reinforcement.
  • Receive a 10 mm × 1.8 mm mini-screw on one side with immediate loading.
  • Receive a 12 mm × 2.0 mm mini-screw on the contralateral side with delayed loading.
  • Receive standardized orthodontic force using elastic power chain.
  • Undergo CBCT assessment to evaluate the position of the inserted mini-screws.
  • Be evaluated at baseline and at one-month intervals for three consecutive months to assess mini-screw mobility or failure.

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
None

入排标准

年龄范围
19 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants aged 19 to 35 years.
  • Both male and female participants.
  • Patients requiring absolute anchorage for maxillary arch and orthodontic tooth movement.
  • Patients undergoing fixed orthodontic treatment.
  • Patients in whom infra-zygomatic mini-screws are indicated for anchorage reinforcement.
  • Participants whose oral hygiene status can be clinically assessed.
  • Participants willing to provide written informed consent.

排除标准

  • Patients with incomplete history or records
  • Patients with a history of previous orthodontic treatment.
  • Patients with a history of maxillofacial surgery.
  • Patients with a history of head or facial trauma.
  • Patients with temporomandibular joint disorder.
  • Medically compromised patients.
  • Patients with diagnosed syndromes, congenital defects, or facial deformities.

研究者

发起方
Tanzila Rafique
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tanzila Rafique

Associate Professor

Bangladesh Medical University

研究点 (1)

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