Efficacy of Root Torque Control in Adult Non-extraction Spacing Cases Treated With Directly 3D Printed Clear Aligners: a Cone Beam Computed Tomography Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 14
- 试验地点
- 3
- 主要终点
- Evaluation of the efficacy of direct 3D printed aligners in achieving the planned root torque of upper and lower incisors .
研究概览
简要总结
This study aims to three-dimensionally evaluate the efficiency of direct 3D printed aligners in achieving the planned root torque by using CBCT and to assess the associated bone thickness changes and root resorption.
详细描述
Participants will be recruited from the Faculty of Dentistry, Beni Suef, Suez Canal, and British Universities. All subjects will be informed of the treatment procedures and will sign a consent form.
the minimum total required sample size (n) was found to be (14) cases. The sample size was calculated using R statistical analysis software version 4.5.0 for Windows[11].
Methodology:
- Cone beam computed tomography scans will be done before treatment (T0).
- Intraoral scanning of the patients will be performed by using an intraoral scanner to obtain pre-treatment digital models of the upper and lower arches. The treatment plan will be set up, and the aligners will be 3D printed.
- The patient will be instructed to immerse the aligners in warm water before inserting them into the mouth to soften them and improve their fit. The patient will be instructed to change the aligners every week.
- At the end of orthodontic treatment (within 9 months - 2 years after the beginning of the treatment), a post-treatment CBCT scan will be obtained (T1)
- The achieved torque movement of the upper and lower incisors will be calculated by evaluated the pre and post CBCT scans taking the difference between T0 and T1.
- The difference between achieved and predicted torque movement (DAPM) will be obtained, and the efficiency will be calculated by dividing the achieved movement / predicted movement X 100 %
- The labial and palatal bone thickness and root length of the upper and lower incisors will be measured at T0 and T1 by using the pre and post cone-beam computed tomography, and the difference will be calculated.
The results will be obtained and statistically analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18- 45 years old.
- •Non- extraction treatment.
- •Angle Class I or Class II dental malocclusion with generalized or localized anterior spacing.
- •Normal probing depth.
排除标准
- •Active periodontal disease.
- •Crowding cases.
- •Systemic diseases or medications that alter bone metabolism or tooth movement.
结局指标
主要结局
Evaluation of the efficacy of direct 3D printed aligners in achieving the planned root torque of upper and lower incisors .
时间窗: 9-12 months
次要结局
- Change in the bone thickness (measured in mm) around the upper and lower incisors associated with the achieved root torque.(9-12 months)
- Assessment of amount of root resorption (measured in mm) of upper and lower incisors associated with root torque.(9-12 months)
研究者
rim fathalla
Rim Mohamed Fathalla Eissa
Suez Canal University