Splintless Virtual Surgical Plan with Mandible-first Technique in Orthognathic Surgery: Tridimensional Accuracy Analysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Accuracy evaluation
研究概览
简要总结
Accuracy assessment through three-dimensional superposition of the post-operative volumetric CT and the digital therapeutic project files.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women
- •Age over 18 and under 60
- •Diagnosis of dento-skeletal dysmorphosis involving the middle third and lower part of the face
- •Patients with consent to surgery
- •Patients in good general health according to the evaluation of the PI and on the basis of the anamnesis and clinical examination
排除标准
- •History of previous maxillomandibular fracture
- •Treatment with anticoagulant drugs
- •Treatment with intravenous bisphosphonates
- •Treatment with anticonvulsants
- •Patient's inability to maintain home hygiene standards in accordance with the study requirements
- •History of drug and/or alcohol abuse
- •Chronic corticosteroid therapy
- •Radiotherapy, chemotherapy and/or immunosuppressive treatment or radiotherapy in the last 5 years
- •Psychosis
- •Pregnant or breastfeeding
- •Poor compliance
- •Endocrinological disorders in poor pharmacological control
- •Other uncontrolled systemic conditions that preclude performing surgical procedures
结局指标
主要结局
Accuracy evaluation
时间窗: 1 month post-op
3D superposition of post-operative volumetric CT and the digital therapeutic project files. The variables and parameters analysis will be performed after the data distribution analysis, using the D'Agostino Pearson omnibus normality test: normal distribution data will be expressed as mean and standard deviation; non-normal distribution data will be expressed as median and interquartile range. The quantitative and qualitative variables will be expressed in terms of absolute frequencies and percentage value. Image superposition accuracy will be defined by measuring distances between the different anatomical reference points, considering excellent accuracy for distances less than 2 mm. Correlation and multivariate analysis models will be developed to define the secondary outcomes.
次要结局
未报告次要终点