跳至主要内容
临床试验/NCT04988373
NCT04988373已完成不适用

Evaluation of the Efficiency of Modified Aligner Appliance With NiTi Springs for Treatment of Mild Crowding Cases in Adults.

Damascus University2 个研究点 分布在 2 个国家目标入组 36 人开始时间: 2021年7月23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
36
试验地点
2
主要终点
Change in Lower Incisors Inclination

研究概览

简要总结

36 participants who have mild crowding from the Orthodontic Department at University of Damascus Dental School will be randomly assigned into two groups.

  1. In the experimental group, patients will be treated using single aligner appliance in order to align their crowding teeth.
  2. Control group will undergo typical orthodontic treatment using an MBT-prescription of metallic brackets.

详细描述

Most adult patients do not prefer traditional fixed appliances for aesthetic reasons, long treatment duration, and relatively difficult oral care. The current study came in order to evaluate the Efficiency of a new single aligner appliance that is both aesthetic and economical.

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
16 Years 至 28 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Adults patients aged between (16 - 28) years.
  • Class I malocclusion with Mild crowding (1 - 4) mm in the anterior region of the mandibular dental arch
  • All lower teeth are existed (except for third molars).
  • No congenitally missing or extracted teeth (except for third molars)
  • Patients have not undergone previous orthodontic treatment.
  • Patient with good oral hygiene (Plaque Index less than 1).
  • With no severe skeletal discrepancy.

排除标准

  • Bimaxillary dentoalveolar severe protrusion.
  • Any systemic diseases affect teeth movement.
  • Bad oral hygiene.
  • Patient lack of commitment toward follow-up appointments.

结局指标

主要结局

Change in Lower Incisors Inclination

时间窗: immediately before the start of orthodontic treatment; T1: at the end of the alignment stage which is expected to happen within 4 to 6 months

The angle between the long axis of the lower Incisors and the mandible plane (Go-Me) will be measured using Cephalometric x ray.

Duration of Alignment

时间窗: The assessment is based on calculating days from the beginning of treatment till the end of the alignment stage which is expected to happen within 4 to 6 months

The time required in days will be calculated from the beginning of treatment till the end of the alignment stage.

Change in Little's Index of Irregularity

时间窗: T0: immediately before the start of orthodontic treatment; T1: after one month; T2: after two months; T3: after three months; T4: after four months; T5: at the end of the alignment stage (which is expected to occur within 4 to 6 months

The irregularity of the lower incisors is calculated by measuring the amount of deviations of the anatomic contact points between the six anterior teeth in the horizontal direction in mm, since the sum of these measurements represents the value of the index (Little, 1975). When the sum of these deviations is less than 3 mm, this indicates that the teeth are slightly crowded. When the sum is greater than 10 mm, this indicated very severe crowding. The ordinary orthodontic treatment aims to keep this Index less than 1 mm at the end of treatment.

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 (2)

Loading locations...

相似试验