Does Subspinal Le Fort I Osteotomy Affect the Nasal Airway Volume
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Evaluation of Septum Deviation
研究概览
简要总结
After the description of Le Fort fractures, maxillary osteotomies are used to correct dentofacial deformities. The profile changes on nasolabial region resulting from a Le Fort I osteotomy, also that affects nasal airway. The Subspinal Le Fort I osteotomy (SLFIO) describe to prevent undesirable soft tissue changes. In the literature, too many articles have reported the effectiveness of SLFIO in preventing nasal deformation. However, there is no study to evaluate the nasal volume or septum deviation.
详细描述
The purpose of this study was objectively and subjectively to compare the effect of Subspinal Le Fort I Osteotomy and Conventional Le Fort I Osteotomy on nasal airway volume and septum deviation without additional modification such as Ans Reduction, Alar Cinch Suture, V-Y closure.
Surgical procedure; Patients were underwent general anesthesia for bimaxillary orthognathic surgery.
The mucoperiosteal flap was raised to expose the bilateral infraorbital foramina, aperture pyriformis, zygomaticomaxillary, and pterygomaxillary buttress. No dissection was performed between the nasal mucosa and the ANS of the patients in Subspinal Le Fort osteotomy group.A triangular osteotomy line was created between the maxilla and the ANS with a piezosurgery. In Conventional osteotomy group, Le Fort I osteotomy was made using a piezosurgical saw after nasal mucosa elevation. In both groups, osteotomes and pterygoid plaques, nasal septum, and lateral nasal walls were separated.
Follow up:
septum deviation and nasal. airway volume value was measured and recorded in the CBCT images taken before the surgery and at the 6th month after the surgery of each patient.
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, Outcomes Assessor)
盲法说明
double blind
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 18-40, ASA I, without systemic disease, without any drug allergy, and without a history of NSAID use in the week before the operation.
排除标准
- •ASA II or higher, hepatic or renal dysfunction, neuropathic disease, long-term use of NSAIDs or opioid-derived drugs, a history of allergic reaction to drugs, pain, swelling, inflammation in the head and neck region before the operation, pregnant and breastfeeding with a history of cleft lip and palate and rhinoplasty surgery
研究组 & 干预措施
Conventional Group
In conventional group, Le Fort I osteotomy was made using a piezosurgical saw after nasal mucosa elevation as usual Le Fort I technique.
干预措施: Conventional (Procedure)
Subspinal Group
In Subspinal group, No dissection was performed between the nasal mucosa and the ANS of the patients. Osteotomy was performed in the subspinal Le Fort I group that is described by Mommaerts . A triangular osteotomy line was created between the maxilla and the ANS with a piezosurgery.
干预措施: Subspinal (Procedure)
结局指标
主要结局
Evaluation of Septum Deviation
时间窗: up to six months
This angle value was measured and recorded in the CBCT images taken before the surgery and at the 6th month after the surgery of each patient. If the angle in the preoperative view is smaller than the angle in the postoperative view, there is a decrease in septum deviation; If it is large, it was accepted that there was an increase in septum deviation.
Evaluation of Nasal Airway
时间窗: up to six months
CBCT scans were scanned for anatomical landmarks to adjust the volume analyzed by automatic segmentation in NemoFAB. Dens endpoint of the axis and nasion were found to be the most consistent at the anterior cranial and posterior caudal borders in the mid-sagittal plane The lateral borders were determined as the most lateral part of the nasal cavity. These markers were used to define the cubic area of interest (ROI), which includes the cranial cavity up to the maxillary base. In the sagittal tomography section, the nasal airway volume was measured in cc on the section taken from the midline.
次要结局
- nasal obstruction scale evaluation(up to six months)
研究者
Selin Celebi
PhD,DDS
TC Erciyes University