Computer Assisted Orthognathic Surgery. Facial Asymmetry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in linear measures
研究概览
简要总结
The specific aims of the study were to measure and compare the rates of alignment and cant reduction of the dental and facial midlines among the two groups.
详细描述
The purpose of this randomized, controlled, clinical study, was to evaluate the most accurate procedure for orthognathic correction of facial asymmetry. The investigators compared two different methods of surgical planning: classical (esthetic analysis of the face, cephalometric study of the skull in lateral and posteroanterior cephalograms, analysis and surgical simulation of plaster casts mounted in semi-individual articulators, development of a surgical acrylic resin intermediate splint) and digital planning (cone-beam computed tomography, data acquisition, software-assisted virtual surgery -Maxilim; Medicim, Mechelen, Belgium- and CAD/CAM processing of the surgical intermediate splint).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 54 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •facial asymmetry or mandibular deviation (cant of the occlusal plane > 3° and/or midline discrepancies > 2.5 mm)
- •presence of all central incisors,
- •pre- and postoperative radiographs and plaster casts (group 1)
- •cranial CBCT images (group 2)
- •pre- and postoperative digital photographs.
排除标准
- •previous trauma involving the hard or soft facial tissues
- •functional deviation of the mandible
- •incomplete records (CBCT, radiographs, casts or digital photographs).
结局指标
主要结局
Change in linear measures
时间窗: Preoperative (baseline)-Postoperative (up to 1 month)
More specifically were measured: distance from the upper interincisal point to the facial midline; distance from the lower interincisal point to the facial midline; distance between interincisal points; distance from skeletal menton to the facial midline; distance from soft tissue menton to the facial midline;
Change in angular measures
时间窗: Preoperative (baseline)- Postoperative (up to one month)
More specifically were measured:distance from the maxillary sagittal plane to the facial mid-sagittal plane; distance from the mandibular sagittal plane to the facial mid-sagittal plane.
次要结局
- gender(Preoperative (baseline))
- age of patients(Preoperative (baseline))
- Type of surgery needed(Preoperative (baseline))
- sample size(Preoperative (baseline))
研究者
Silvio Mario Meloni
DDS, PhD, Assistant Professor
Università degli Studi di Sassari