A Prospective Clinical Trial Comparing the Alignment Achieved Using Computer-guided Indirect Bonding of Orthodontic Brackets to Conventional Orthodontic Appliance Placement
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
- 是
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
Mohamed Masoud
Principal Investigator
Harvard School of Dental Medicine
