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临床试验/NCT07169968
NCT07169968进行中(未招募)不适用

Evaluation of the Effects of Micro-Osteoperforations on The Efficiency of Orthodontic Clear Aligner Therapy for Alleviating Mandibular Anterior Crowding: A Randomized Clinical Trial

Ain Shams University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年8月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
20
试验地点
2
主要终点
aligner effectivness

研究概览

简要总结

this randomized controlled trial is designed to compare between clear aligner therapy in alleviating mandibular anterior crowding alone versus with micro-osteoperforations

详细描述

This study is carried on in order to provide a method to enhance the predictability of clear aligner treatment. Loss of aligner tracking is one of the problems encountered during aligner treatment that results in increasing number of aligners required to complete treatment in addition to increasing the overall treatment time and cost. Micro-osteoperforation is a method for acceleration of orthodontic tooth movement and could be used to improve tooth movement and predictability of treatment with clear aligners. So this study is aimed to evaluate the efficiency of aligner treatment during alleviation of lower anterior crowding with and without micro-osteoperforations

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, Care Provider)

入排标准

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

入选标准

  • Adult patients with age ranging from 18 to 35 years.
  • Healthy periodontium.
  • Presence of full set of permanent dentition excluding third molars.
  • Patients requiring non-extraction orthodontic treatment in the mandibular arch.
  • Mandibular anterior little's irregularity index from 3 to
  • No spaces in the mandibular arch.

排除标准

  • Presence of retained primary teeth in the mandibular arch.
  • Patients having systemic diseases as (e.g., diabetes, osteoporosis) or taking medication that could affect tooth movement (e.g., bisphosphonates, anticancer drugs)
  • Vulnerable patients.
  • Pregnant female patients.

结局指标

主要结局

aligner effectivness

时间窗: 3-9 months

Number of aligners prescribed versus required (total number of aligners including refinements) for each group

次要结局

  • tooth mobility assessment(3-9 months)
  • relief of dental crowding(3-9 months)
  • gingival assessment(3-9 months)
  • pain assessment(from day 1 to day 7 after micro-osteoperforations)
  • periodontal assessment(3-9 months)
  • relief of dental crowding(3-9 months)
  • gingival assessment(3-9 months)
  • pain assessment(from day 1 to day 7 after micro-osteoperforations)
  • periodontal assessment(3-9 months)
  • tooth mobility assessment(3-9 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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