Three Dimensional Evaluation of Nasolabial Changes Following Classic Versus Modified Alar Base Suture After Le Fort I Osteotomy
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- Widening of the alar base
研究概览
简要总结
Three dimensional evaluation of nasolabial changes following classic versus modified alar cinch suture after Le Fort I osteotomy using cone beam computed tomography
详细描述
Intra operative procedures: (For all groups) All surgical operations will be performed or supervised by one of the authors (MdK). Intraoperative antibiotics will be given(1000 mg cefazolin and 500 mg metronidazole). After nasotracheal intubation, the mucobuccal fold of the maxilla will be infiltrated with local anaesthetic (articaine ; Ultracain DS Forte). The Le Fort I procedure will be started with an incision in the gingivobuccal sulcus from the canine on the one side to the canine on the other side. After elevation of the mucoperiosteum and nasal mucosa, the osteotomy line will be designed with a fine burr, after which the cut will be made with a reciprocal saw. The lateral nasal walls and nasal septum will be osteotomized with a nasal osteotome. The piriform aperture and when necessary the nasal spine will be rounded off. After mobilization of the maxilla, it will be positioned in the planned position using an acrylic wafer. Fixation will be performed with four 1.5-mm miniplates, one paranasal and one on the buttress on each side. The mucosa will be closed with a 4-0 Vicryl suture (Ethicon ; Johnson and Johnson Medical, Norderstedt, Germany).
The alar cinch procedure will be performed through the intraoral incision as follows:
In the comparator ( control ) group:
The classic method of alar cinching will be performed in the following manner: An index finger will be used to apply extraoral pressure on the alar base region, and a dentate forceps will grasp this tissue through the intraoral incision. A suture bite will be taken at this point through the tissue previously held by the forceps. The same procedure will be applied on the opposite side. After passing the suture on both sides, it will be tightened with attention to the alar base response. If the alar base suture will be judged to be adequate, the vestibular incision will then be closed in a routine fashion, with or without performing a V-Y lip closure.
In the intervention group:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double blind clinical trial
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
- •Adult patients with skeletal maxillomandibular deformity indicated for surgical correction by Le Fort I osteotomy.
- •Absence of clefts.
- •Absence of growth.
- •Patients must be willing for the surgical procedure and follow-up, with his informed consent.
排除标准
- •History of facial trauma with fractures of facial bones.
- •History of surgical operation in nasal region.
- •Facial asymmetry.
- •Patients with accompanying craniofacial syndromes.
- •Patients with any diseases that compromise bone or soft tissue healing.
- •Anterior open bite cases
- •Medically compromised patients not fit for general anaesthesia.
研究组 & 干预措施
1st group
20 patients out of 40 will be enrolled into the study including males and females above 18 years old
干预措施: Classic alar base suture technique (Procedure)
2nd group
20 patients out of 40 will be enrolled in the study including males and females above 18 years old
干预措施: Modified alar base suture technique (Procedure)
结局指标
主要结局
Widening of the alar base
时间窗: 6 months postoperatively
Postoperative increase in the alar base width in millimeters(mm) in comparison to the normal preoperative alar base width
次要结局
- Nasal volume(6 months postoperatively)
研究者
Amr Samy
Oral and Maxillofacial surgeon
Cairo University