The Nasal Changes Affected by 2 Different Alar Base Suture Techniques After Maxillary LeFort I Osteotomy--A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Soft and Hard Tissue Landmarks Movement
研究概览
简要总结
study hypothesis
- The aim of this study:
How can the investigators predict and control the nasal changes after maxillary LeFort I osteotomy with 2 different alar base suture techniques ? 2. Study hypothesis
- Null hypothesis: Nasal changes were not affected by 2 different alar base suture techniques after maxillary LeFort I osteotomy
- Alternative : Nasal changes were affected by 2 different alar base suture techniques after maxillary LeFort I osteotomy
详细描述
Background and study purpose:
Patients who received maxillary LeFort I osteotomy often complained about their nose become wider and more nostril show after surgery. According the the literature review, the conventional and modified alar base cinch technique both could control the interalar width. However, there is no long term result show which technique is superior to the other. Therefore, in order to improve patients' nasal and midfacial esthetics after the surgery, this study is to evaluate how the nasal changes affected by 2 different alar base cinch suture and which technique could result in a more positive effect.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Taiwanese patients who received LeFort I osteotomy at CGMH during 2011-2012
- •No previous craniofacial surgery
- •Patients agreed to attend this study and willing to sign the agreement
- •Patients who are elder than 18 years old and after growth completion
排除标准
- •Craniofacial anomalies
- •cleft lip and /or palate patients
- •patients without all the documents
- •patients do not receive combined correcting nasolabial shape and orthognathic surgery.
结局指标
主要结局
Soft and Hard Tissue Landmarks Movement
时间窗: The hard tissue movements were assessed after surgery 4-6 weeks.The soft tissue movements were assessed after surgery 6 months.
The investigator measured the movement (1 month minus baseline) of hard tissue landmarks before and after 4-6 weeks maxillary LeFort I osteotomy. The movement (6 months minus baseline) of soft tissue landmarks was measured before and after 6 months of the maxillary LeFort I osteotomy. The 3D directional movement of each point was measured in the x(transverse), y(vertical), and z (antero-posterior)planes. The positive directional movement of each point in X axis means the point moved left after surgery, and negative directional movement in X axis means the the point moved right after surgery. The positive directional movement in Y axis means the point moved upward after surgery, and negative directional movement in Y axis means the the point moved downward after surgery. The positive directional movement in Z axis means the point moved anteriorly after surgery, and negative directional movement in Z axis means the the point moved posteriorly after surgery.
次要结局
- 14 Nasolabial Linear Parameters(up to post-operation 6 months)
- 1 Nasolabial Angular Parameters(up to post-operation 6 months)