Direct vs Digitally Guided Palatal Miniscrew Placement for MARPE: A Randomized Clinical Trial on Accuracy, Stability, and Anatomical Safety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mean coronal deviation between planned and achieved miniscrew position
研究概览
简要总结
This randomized clinical trial compared the accuracy, primary stability, and anatomical safety of two protocols for palatal miniscrew placement in adolescents requiring maxillary skeletal expansion. Participants were randomly assigned to either direct appliance-guided miniscrew placement for MARPE or digitally guided CAD/CAM-assisted miniscrew placement. Postoperative CBCT imaging was used to assess placement accuracy and anatomical safety, while clinical evaluation was used to assess primary stability.
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
- None
盲法说明
Due to the nature of the interventions, blinding of participants, care providers, investigators, and outcome assessors was not feasible. The study was conducted as an open-label randomized clinical trial.
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 12 and 18 years
- •Transverse maxillary deficiency requiring skeletal expansion
- •Midpalatal suture maturation stage B or C
- •Adequate palatal bone height for miniscrew insertion (≥9 mm)
- •No previous maxillary expansion treatment
排除标准
- •Age >18 years
- •Palatal bone height <6 mm
- •Systemic disease affecting bone metabolism
- •Medication affecting bone turnover
- •Craniofacial syndromes or cleft conditions
结局指标
主要结局
Mean coronal deviation between planned and achieved miniscrew position
时间窗: Immediately after miniscrew placement
Coronal deviation (mm) measured on postoperative CBCT by comparing the planned and achieved miniscrew positions.
Mean apical deviation between planned and achieved miniscrew position
时间窗: Immediately after miniscrew placement
Apical deviation (mm) measured on postoperative CBCT by comparing the planned and achieved miniscrew positions.
Mean angular deviation between planned and achieved miniscrew position
时间窗: Immediately after miniscrew placement
Angular deviation (degrees) measured on postoperative CBCT by comparing the planned and achieved miniscrew positions.
次要结局
- Number of miniscrew failures before expansion activation(At 8 weeks after miniscrew placement)
- Number of miniscrews with nasal cavity or maxillary sinus invasion assessed by postoperative CBCT(Immediately after miniscrew placement)
研究者
Ignacio Arcos Palomino
Phd ij Medicien, Doctor Dental Surgery, MSc in orthodontics
Universitat Internacional de Catalunya