Efficacy of Orthodontic Tooth Movement Using Beveled and Conventional Attachments in Aligners: a Randomized Split-Mouth Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Neodent
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- To evaluate the efficacy of dental movement using beveled and conventional attachments
研究概览
简要总结
The objective of this study is to evaluate the efficacy of tooth movement using beveled attachments and conventional attachments. The sample will be consecutively selected, comprising participants seeking orthodontic treatment in a private dental office within the recruitment period (from ethics committee approval to July 2027). Participants will be selected and randomized using a split-mouth study design. Groups will be divided into rectangular and beveled attachments, each further subdivided into subgroups for horizontal movements (Group H), vertical movements (Group V), and rotations (Group R), with 20 teeth/attachments per group, totaling a sample of 120 teeth/attachments. Digital study models will be obtained before the start of treatment and immediately after its completion. Additionally, clinical intraoral and extraoral photographs will be taken (pre- and post-treatment). Measurements will be collected from the initial and final digital models to determine the magnitude and direction of movements resulting from treatment. Descriptive statistics will be calculated for each type of dental movement evaluated. Paired tests will be conducted due to the split-mouth design. Correlation tests will be applied if necessary.
详细描述
Participant recruitment will take place after approval by the Research Ethics Committee until July 2027. The consultations will occur in a private clinic in Curitiba - PR, Brazil.
Participants will be selected and randomized according to the split-mouth study design. Teeth on each side will have different attachment configurations to aid orthodontic aligner movements. One side will use rectangular attachments, and the other side will use beveled attachments. Groups will be divided as follows:
Group H: 20 teeth/attachments with horizontal displacements (parallel to the occlusal plane) including tipping or mesio-distal translation - premolars and molars.
Group V: 20 teeth/attachments with vertical displacements (extrusion and intrusion) - incisors.
Group R: 20 teeth/attachments with mesio-distal rotations - canines and premolars.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults (18+ years) with permanent dentition
- •Candidates for aligner-based orthodontic treatment
- •Require bilateral tooth movements (e.g., extrusion, intrusion, rotation, tipping, mesiodistal translation)
- •Provide written informed consent
排除标准
- •Contraindications to aligner use (e.g., manufacturer's guidelines)
- •Poor oral hygiene, active periodontal disease, or TMJ disorders
- •Allergies to aligner materials (e.g., polyurethane, PETG)
结局指标
主要结局
To evaluate the efficacy of dental movement using beveled and conventional attachments
时间窗: From enrollment to the end of treatment, not exceeding 24 months.
Difference between the planned movement and the achieved movement, and the percentage of orthodontic dental movement achieved.
次要结局
- To measure dental movements achieved with the treatment.(From enrollment to the end of treatment, not exceeding 24 months.)
- Measure the transverse dental changes achieved.(From enrollment to the end of treatment, not exceeding 24 months.)
- To assess participant satisfaction throughout the treatment.(From enrollment to the end of treatment, not exceeding 24 months.)