Accuracy of Dental Movements Using Clear Aligners Treatment: a Single-center Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Evaluate accuracy aligners of on transversal dental linear movements
研究概览
简要总结
The aim of the present prospective observational study is to evaluate the accuracy of dental movements in the three planes of space, assessing the correspondence between the virtual planned movements and the clinical outcomes achieved using thermoformed or 3D printed orthodontic aligners. The study will include patients who are candidates for aligner orthodontics treatment. After having acquired the standard initial diagnostic data (clinical examination, intra- and extra-oral photographs, intra- and extra-oral scans, orthopantomography and lateral-lateral teleradiography of the skull), the digital impressions of the arches will be used to plan the dental movements necessary for correction of malocclusion.
The aligners will then be designed using orthodontic CAD software and realized using a thermoformed and direct 3D printing process.
All patients will be treated following current recommendations relating to the orthodontic treatments in question. After delivery of the aligners, during each check-up, intra-oral and extra-oral scans will be acquired to evaluate the actual position of the teeth and, using special software will be compare the virtually designed position with tooth with the clinical outcomes. Any discrepancies will be recorded and statistically analyzed.There are no additional invasive procedures. Intra- and extra-oral scans will be acquired regularly to monitor the extent of tooth movement over time.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 65 years
- •Good general health
- •Presence of a dental/skeletal malocclusion
- •Permanent dentition with second molars completely erupted in the arch
- •Correct tooth shape, with sufficient height of the clinical crowns
- •Good compliance during treatment
排除标准
- •Systemic diseases or pharmacological therapy with drugs that can affect orthodontic movement
- •Orofacial malformations or syndromes
- •Periodontal disease
- •Signs and/or symptoms of temporomandibular disorders
- •Absence of teeth (except for third molars)
- •Dental Implants
结局指标
主要结局
Evaluate accuracy aligners of on transversal dental linear movements
时间窗: 18 months
Correspondence between virtual planned linear movements (in millimetres) and clinical outcomes achieved using aligners evaluated on the transversal plane. Post-treatment digital models and final virtual treatment plan models will be exported as STL files and subsequently imported into Geomagic Qualify ®software, to compare final teeth positions
Evaluate accuracy aligners of on vertical dental linear movements
时间窗: 18 months
Correspondence between virtual planned linear movements (in millimetres) and clinical outcomes achieved using aligners evaluated on the vertical plane. Post-treatment digital models and final virtual treatment plan models will be exported as STL files and subsequently imported into Geomagic Qualify ®software, to compare final teeth positions
Evaluate accuracy aligners of on sagittal dental linear movements
时间窗: 18 months
Correspondence between virtual planned linear movements (in millimetres) and clinical outcomes achieved using aligners evaluated on the sagittal plane. Post-treatment digital models and final virtual treatment plan models will be exported as STL files and subsequently imported into Geomagic Qualify ®software, to compare final teeth positions
次要结局
- Evaluate accuracy of 3d printed aligners on sagittal dental angular movements(18 months)
- Evaluate accuracy of 3d printed aligners on vertical dental angular movements(18 months)
- Evaluate accuracy of 3d printed aligners on transversal dental angular movements(18 months)
研究者
Giorgio Gastaldi
Associate Professor
IRCCS Ospedale San Raffaele