Stability of Maxillary Advancement by Lefort I Osteotomy in Patients With Retruded Maxilla Fixed With Two Prebent Plates Versus Four Miniplates. (Randomised Clinical Trial.)
试验速览
- 阶段
- 不适用
- 入组人数
- 12
- 主要终点
- Maxillary stability
研究概览
简要总结
In patients with retruded maxilla ,Will the use of two prebent plates produce more stable results postoperatively in fixation of Le Fort I osteotomy in maxillary advancement than conventional four minplates ? Many studies have been conducted to compare between the two plates and these studies showed that the prebent plate, the plate is not excessively twisted so that it can be adapted passively leading to less changes in the property of the material ,increased titanium contact surface to the bone leading to better force distribution resulting in better rigid fixation as no stresses will be transmitted from the plate to the bone leading to faster bone healing and consequently better long term postoperative stability.
详细描述
The stability of maxillary advancement after Le Fort I osteotomy in retruded maxilla patients has been an issue that has attracted the attention of numerous researchers. That's why different fixation methods have been compared in vitro and in vivo.
Prebent plates is one of the recent modifications of the plate systems used in maxillofacial surgery , they were created to reduce the need for bending and contouring of the titanium miniplates.
Lye et al.,(the only in vivo study in English), aimed to evaluate the predictability of advancement surgery with the use of prebent plates in 36 patients & he proved the prebent plates have been proven to significantly affect the advancement & reliable.
In a biomechanical study, prebent plates provided better results than the standard two plate scenario in terms of resistance to displacement, permanent deformation and load for breaking.
Fatih Mehmet Coskunses et al., in 2015 has done in vitro study to evaluate the segmental displacement, and von mises stress on the titanium miniplates & the maximum principal stress on the bone, with the use of prebent plates and two standard L plates adapted to either the zygomaticomaxillary buttress or the nasal piriform following anterior advancement of 5 mm or 10 mm by Le Fort I osteotomy.
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
- Single (Participant)
盲法说明
Cards will have sequential numbers one number for each card then these cards will be placed within opaque sealed envelopes. Then these envelops will be placed in a container (box), each participant will grasp one envelope the day of procedure.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with retruded maxilla & need advancement by le fort I osteotomy.
- •Patients free from any systemic disease & bone metabolism diseases.
- •Patients with no signs or symptoms of temporomandibular joint disorders.
- •No sex predilection
- •Age range ( 18-45)
排除标准
- •Patients with systemic disease & bone metabolism diseases.
- •Patients with cleft lip & palate.
- •Patients with temporomandibular joint disorders
- •Patients receiving chemotherapy or radiotherapy "due to the risk of low bone quality and healing
- •Age less than 18
研究组 & 干预措施
prebent plate
fixation of le fort I osteotomy using prebent plate
干预措施: lefort I osteotomy for maxillary advancement (Procedure)
Conventional four miniplates
fixation of le fort I osteotomy using conventional four miniplates
干预措施: lefort I osteotomy for maxillary advancement (Procedure)
结局指标
主要结局
Maxillary stability
时间窗: 12 months
Linear measurements (from A point to the nasion perpendicular, A point perpendicular to Frankfort plane) \& Angular measurements (SNA , Maxillary depth angle ) will be obtained from the immediate postoperative lateral cephalometry and after 12 months.
次要结局
未报告次要终点
研究者
Hagar Mahmoud Ahmed Mohamed
Resident of Oral and Maxillofacial Surgery - Nasser Institute Hospital for research & treatment / Master Candidate of Oral & Maxillofacial surgery, Cairo University
Cairo University