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临床试验/NCT02221856
NCT02221856Unknown不适用

A Prospective Clinical Trial Comparing the Alignment Achieved Using Computer-guided Indirect Bonding of Orthodontic Brackets to Conventional Orthodontic Appliance Placement

Harvard School of Dental Medicine2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年2月8日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
Discrepancy between predicated and actual tooth positions

研究概览

简要总结

Technological advances have made computer aided orthodontic treatment planning possible. 3D dental scanners and software make it possible to design and approve the outcome before treatment begins. Manufacturers have provided different customized appliance systems that would help practitioners achieve those computer-designed outcomes. The purpose of this study is to determine the accuracy of computer-guided indirect bonding of orthodontic brackets at achieving the predicted alignment and comparing that to the accuracy of conventional orthodontic bracket placement at achieving a predetermined goal. The results of this study will help orthodontists and patients know if there is an advantage to using custom appliances. The study will be a prospective clinical study and will include a total of 60 arches from 30 patients enrolled at the Harvard School of Dental Medicine. 15 patients will be assigned to each of the two study groups (Motion View or control). Both groups will have a 3D intra-oral scan to measure the initial discrepancy and determine the computer-simulated design that the orthodontist believes is the optimized outcome. At the end of each patient's participation, a 3D intraoral scan will be taken and used to assess intra-arch leveling and alignment using ABO's objective grading system's criteria for alignment, marginal ridges and buccolingual inclination. Each arch will then be superimposed on the predicted outcome to determine how accurate each system was at achieving the planned movements in all 3 dimensions. We hypothesize that the accuracy of computer-guided indirect bonding (Motion View) at achieving the predicted outcomes will differ in comparison to the accuracy of conventional orthodontic bracket placement at achieving a predetermined goal.

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
— 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy subjects seeking orthodontic care
  • All permanent teeth must be erupted, excluding second and third molars
  • Class I, II, and III cases
  • No more than 7 mm crowding
  • No more than 45 degrees of rotations

排除标准

  • Presence of systemic disease
  • Craniofacial anomalies, including cleft lip and palate
  • Syndromes affecting bone or teeth
  • Congenitally missing teeth, excluding third molars
  • Presence of bridges or implants
  • Periodontal disease
  • Use of drugs affecting tooth movement or bone metabolism (NSAIDS, bisphosphonates, PTH, corticosteroids)
  • Pregnancy

结局指标

主要结局

Discrepancy between predicated and actual tooth positions

时间窗: up to 12 months

次要结局

  • assessed quality of treatment measured by the American Board of Orthodontics (ABO) objective grading system(up to 12 months)

研究者

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

Mohamed Masoud

Principal Investigator

Harvard School of Dental Medicine

研究点 (2)

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