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临床试验/NCT07053189
NCT07053189已完成不适用

Effects of Interproximal Reduction and Attachment Application on Effectiveness of Rotational Tooth Movement in Clear Aligner Therapy

Lokman Hekim Üniversitesi1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2019年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
35
试验地点
1
主要终点
Change in tooth rotation (degrees) from baseline (T0) to refinement (T1), measured from Clincheck software

研究概览

简要总结

This study is testing whether clear aligners (Invisalign®) can help fix teeth that are rotated. The researchers want to learn if using two common methods-interproximal enamel reduction (IPR) and attachments-makes rotation correction more successful.

Participants in the study will wear custom-made aligners for about 20 to 22 hours every day. They will switch to a new set of aligners every 2 weeks.

The study will look at tooth movement over time by using a digital planning tool called ClinCheck®, which helps plan and measure how much teeth have moved.

The researchers want to answer three main questions:

Do Invisalign® aligners work well for correcting rotated teeth?

Does IPR help improve rotation correction?

Do attachments help improve rotation correction?

The goal is to understand whether these tools work better together or separately to move teeth into better alignment.

详细描述

This study is about clear aligners, which are plastic trays that gently move teeth. The researchers want to know how well aligners can fix teeth that are rotated (turned out of their normal position). They also want to test whether two common tools-interproximal enamel reduction (IPR) and attachments-help aligners work better when correcting rotated teeth.

IPR means gently shaving a small amount of enamel between teeth to make space for movement.

Attachments are small, tooth-colored bumps added to teeth to help the aligners grip better and apply more force.

The study includes 35 participants who are being treated with Invisalign® clear aligners. All of them have full adult teeth (except wisdom teeth), mild to moderate crowding, and a type of bite called Class I malocclusion.

Participants wear their aligners for 20 to 22 hours a day, changing to a new set every 2 weeks. The average treatment includes about 18 aligners.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •Adults with full permanent dentition (excluding wisdom teeth)
  • •Angle Class I malocclusion
  • •Mild to moderate crowding in the upper and lower arches
  • •Planned treatment with clear aligners for both jaws
  • •Rotated teeth within the correction limits recommended by Align Technology®
  • •Willing and able to wear aligners for 20-22 hours per day
  • •Able to attend follow-up visits every 2 aligners (~4 weeks)

排除标准

  • •Previous orthodontic treatment
  • •Need for additional orthodontic appliances (e.g., elastics or rubber bands)
  • •Periodontal disease or other active oral health problems
  • •Presence of prosthetic dental work (e.g., crowns or bridges)
  • •Need for tooth extraction during aligner treatment
  • •Medical conditions that may interfere with orthodontic treatment compliance

研究组 & 干预措施

Rotational tooth movement in clear aligner therapy

Experimental

干预措施: Clear Aligner treatment (Device)

结局指标

主要结局

Change in tooth rotation (degrees) from baseline (T0) to refinement (T1), measured from Clincheck software

时间窗: 36,9 weeks

Comparison of tooth rotation correction with IPR and attachments

次要结局

未报告次要终点

研究者

发起方
Lokman Hekim Üniversitesi
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Aylin Alaçam

Asis.Prof.,Lokman Hekim University, Faculty of Dentistry, Department of Orthodontics

Lokman Hekim Üniversitesi

研究点 (1)

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