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临床试验/NCT07608302
NCT07608302已完成不适用

Comparison of the Predictability of Dentoalveolar Expansion With Two Clear Aligner Systems: Angel Aligner Pro-Angel Aligner and Invisalign. A Longitudinal Clinical Study in Adult Patients.

University of Salamanca1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年2月13日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1

研究概览

简要总结

To analyze the clinical predictability of transverse arch expansion achieved with two clear aligner systems (Invisalign, Angel Aligner-Angel Aligner Pro) by comparing planned and achieved dental movements through digital model analysis at different treatment stages using a repeatable and reproducible digital measurement technique.

详细描述

The study population comprised 60 adult subjects (mean age: 33.93 ± 8.38 years) presenting with transverse maxillary and mandibular deficiencies requiring dentoalveolar expansion with clear aligners in both arches. Participants were divided into three homogeneous groups of 20 patients treated with different aligner systems: Angel Aligner-Angel Aligner Pro (Angelalign Technology Inc., Shanghai, China), and Invisalign (Align Technology Inc., San Jose, CA, USA). Digital models of the maxillary and mandibular arches were obtained at baseline (T1) using an iTero Element 5D intraoral scanner. Virtual treatment planning was performed using iOrtho (version 5.2) and ClinCheck (version 6.0 Pro) software, generating a virtual setup model (T2) that served as the reference for calculating prescribed orthodontic movements. After aligner fabrication, composite attachments were bonded using standardized protocols and manufacturer-provided templates to ensure reproducibility and accurate expression of planned tooth movements. Digital STL models obtained before treatment, after virtual setup, and at the end of treatment were analyzed using a repeatable and reproducible digital measurement technique to evaluate the predictability of transverse dentoalveolar expansion achieved with each aligner system.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
25 Years 至 43 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients with a full permanent dentition
  • Absence of auxiliary orthodontic appliances
  • A clinical indication for transverse expansion in both dental arches
  • Complete diagnostic and treatment records
  • Treatment plans involving a minimum of 15 aligners before any refinement phase
  • Confirmed adequate compliance with aligner wear (20-22 hours per day)
  • patients with skeletal Class I or mild skeletal Class II or III relationships (ANB angle ranging from 0° to 4°

排除标准

  • Severe dental crowding (tooth size-arch length discrepancy exceeding -5 mm)
  • Active periodontal pathology
  • Treatment plans involving dental extractions

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elena Calzadilla Suárez

Principal Investigator

University of Salamanca

研究点 (1)

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