跳至主要内容
临床试验/NCT07236775
NCT07236775已完成不适用

Evaluation of the Apical Root Resorption in Young Adults Caused by Orthodontic Treatment of Class I Severe Crowding Cases Using Clear Aligners Versus Traditional Fixed Appliances: A Randomized Controlled Clinical Trial

Damascus University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年11月10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
入组人数
40
试验地点
1
主要终点
Change in root length

研究概览

简要总结

Patients with severe crowding requiring the extraction of four premolars will be enrolled in this study. The degree of apical root resorption associated with using the clear aligner technique compared with vestibular fixed appliances in the treatment of severe crowding malocclusion cases requiring the extraction of first premolars will be evaluated using cone beam computed tomography (CBCT) volumes.

There are two groups:

First group (Experimental): the patients in this group will be treated using clear aligners.

Second group (Control): the patients in this group will be treated using fixed appliances.

详细描述

With the increasing number of young adults requesting esthetic orthodontic treatment, clear aligners have continued to gain widespread use, driven by greater consideration of esthetic aspects and oral health-related quality of life compared to traditional fixed orthodontic appliances. Recently, clear aligners have been used in more complex malocclusion cases that require premolar extraction. Teeth root resorption occurs due to physiological or pathological causes that lead to loss of tooth structure. Apical root resorption (ARR) is a common side effect of orthodontic treatment that requires careful investigation of its location and frequency.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult patients aged 18-25 years.
  • •Class I malocclusion with severe dental crowding.
  • •Tooth size-arch discrepancy more than 6 mm.
  • •No congenitally missing or extracted teeth (except for the wisdom teeth).
  • •No history of previous trauma to the maxillofacial region or surgical interventions.

排除标准

  • •Previous orthodontic treatment.
  • •Presence of previously occurred ARR.
  • •Patients with psychological abnormalities or systemic diseases.
  • •Patients with known allergies to latex or plastic materials.

研究组 & 干预措施

Clear Aligners

Experimental

Patients in this group will be treated using clear aligners.

干预措施: Clear Aligners (Device)

Fixed appliances

Active Comparator

Patients in this group will be treated using ordinary fixed appliances.

干预措施: Traditional fixed appliances (Device)

结局指标

主要结局

Change in root length

时间窗: First assessment: one day before the commencement of treatment (i.e., initiating orthodontic tooth movement). Second assessment: one day following the end of treatment (which is expected to occur within 12 to 18 months).

The maximum linear lengths between the root apex and incisal edges (for the anterior teeth) or the cusp tips (for the posterior teeth) will be measured on the cone-beam computed tomography (CBCT) images. Differences between the measurements of each tooth before and after treatment provided the amount of apical root resorption in mm. The variable will be measured for each tooth (from the central incisors to the first molars) and on both jaws.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验