The Predictability of Directly Printed Shape Memory (Graphy) Versus Thermoformed Clear Aligners: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- predictability of tooth movement
研究概览
简要总结
The study is randomized controlled trial ...The null hypothesis suggests that there is no significant difference between actual and predicted dental movement in patients treated using direct printed aligners produced with Graphy™ Tera Harz TA-28 resin as compared to those treated with thermoformed clear aligners.
详细描述
the patients will be randomly assigned to one of two study groups which either direct printed or thermoformed clear aligner. All patients would be given the same instructions: aligners had to be worn for at least 22 hours per day, except during meals and oral hygiene activities, and should be changed every 10 days.Teeth positions would be planned according to esthetic and functional principles, starting with the 3D T0 digital model and aligning and leveling dental arches following orthodontic aligner biomechanical principles. Each aligner had a planned movement speed of 0.2 mm linear displacement, 2° long-axis rotation, and a vestibulo-lingual inclination of 2.5°.
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 (Participant)
入排标准
- 年龄范围
- 16 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with mild to moderate malocclusion that can be treated by less than 40 steps of aligner treatment, including those with dental rotation of < 30°, diastema or crowding of < 8 mm.
- •Patients aged ≥ 16 years with fully erupted permanent teeth (regardless of the third molar).
- •No supernumerary teeth, no enamel malformation.
- •No tooth shape anomalies
排除标准
- •Systemic pathologies such as uncontrolled diabetes or heart diseases
- •active or past periodontal disease
- •previous orthodontic treatment
- •temporomandibular joint disorders
- •ongoing pharmacological treatment could influence orthodontic treatment.
研究组 & 干预措施
Direct-printed aligner (Graphy)
Patients will be treated with direct-printed Graphy aligners until dental levelling alignment; space closure is finished.
干预措施: Direct-printed aligner (Graphy) (Device)
Thermoformed aligner
Patients will be treated with thermoformed aligners until dental alignment, levelling, space closure is finished.
干预措施: Thermoformed aligner (Device)
结局指标
主要结局
predictability of tooth movement
时间窗: 12 months
The primary outcome will be calculated as the percentage difference between the final and initial positions for each individual tooth movement assessed and will be expressed as a continuous numerical variable representing tooth movement predictability (%).
次要结局
- predictability within different types(12 months)
- Colour change of clear aligners(12 months)
- Degree of Conversion(12 months)
- shape memory effect(12 months)
研究者
Hussin Anwar
Dentist.. PhD student
University of Baghdad