Randomized Clinical Trial on the Efficacy and Effectiveness of Two Types of Aligners Based on Stratification by Type of Movement.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Predictability for each type of tooth movement in patients with direct-printed aligners compared to a control group in which the movements are performed with thermoformed aligners.
研究概览
简要总结
The purpose of this study is to evaluate the biomechanical behaviour of direct-printed and thermoformed aligners in different tooth movements, creating a biomechanical planning protocol based on a stratification of tooth movements according to the degree of predictability.
详细描述
Once the objectives, benefits, risks and follow-up of the study have been explained to each eligible patient, patients will be asked to sign an informed consent form. They will also be informed that they may cancel their participation in the study at any time. Patient will be allocated randomly in two groups: The first group will receive orthodontic treatment with direct-printed aligner, while the second group will receive orthodontic treatment with conventional or gold standard thermoformed aligner.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with malocclusion and invididual dental malpositions requiring orthodontic treatment
- •Adequate oral and periodontal health, with absence of periodontal disease, periapical infection or untreated caries.
- •No history of previous orthodontic treatment.
- •Complete permanent dentition (excluding third molars, their presence or absence being irrelevant).
排除标准
- •Altered bone metabolism (including use of antiresorptive, steroid or immunosuppressive drugs).
- •Pregnant women.
结局指标
主要结局
Predictability for each type of tooth movement in patients with direct-printed aligners compared to a control group in which the movements are performed with thermoformed aligners.
时间窗: Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months.
The primary outcome will be quantified through a continuous numerical variable, tooth movement efficiency or predictability (%) measured as the change between the final, intra-treatment and initial position for each of the individual movements studied, expressed as a percentage (%). The end of treatment or endpoint (E1) of this study will be established when the measurement of Little's Irregularity Index (hereafter LII) LII=0.
impact on the effectiveness and predictability of biomechanics auxiliaries compared to a control group in which movements are performed without the use of auxiliaries.
时间窗: Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months.
This will be assessed by quantifying the change between the predictability with auxiliaries and without auxiliaries for each of the individual movements studied respectively, expressed as a percentage (%).
次要结局
- PROMs of the patient undergoing direct-printed aligner treatment compared to the control group.(These should be completed five times after each visit (at 24 hours, 48 hours, 72 hours, 7 days and 14 days of aligner use) until reaching the defined endpoint (crowding resolution, LII=0), an average of 6 months.)
- influence on the printed orthodontic device (POD) of varying the degree of inclination of the aligner print.(Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months.)