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临床试验/NCT02350803
NCT02350803已完成2 期

Dose Use of Rigid Fixation After Removing the Distraction Device Reduce the Anterior-posterior Relapse or Not?

Shiraz University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年2月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
20
试验地点
1
主要终点
"A point" of lateral cephalometry X-ray

研究概览

简要总结

patients were enrolled by the inclusion criteria and were undergo lefort 1 maxillary osteotomy. after the latency phase the distraction was done in anterior- posterior vector. patients were divided by randomized allocation in 2 groups. in group 1 the distractor was removed after consolation phase, and in group 2 fixation devices were placed immediately after removal of distractors. data regarding relapse were analyzed by lateral cephalogram X-ray taken in 3 different phases of the trial. change of occlusal plane and the "A point" of the cephalometric analysis were determined as reference point of the study.

详细描述

All patients were undergo maxillary Lefort 1 osteotomy with intra oral distractors bilaterally. The latency phase was considered 5 days for all of them. Distraction was done in the anterior- posterior vector with 1 mm/day rate. In group 1 distraction devices were removed after finishing distraction and a 3 months consolation, in group 2 fixation devices (4 L shaped miniplates with 16 screws) were placed immediately after removing distractors.

The amount of horizontal and vertical relapse were determined in the "A point" 2 years after finishing distraction.

By using lateral cephalogram X-ray as a raw data base, taken in 3 occasions: preoperatively, immediately after finishing consolation phase and removing distractor with placing fixation devices or without them and 2 years postoperatively in every subject. Relevant skeletal points were determined and digitized to evaluate 2-dimensional skeletal changes during and after surgery and to subsequently determine the amount of relapse. The same X-ray machine and settings were used for all cephalograms.Patients were stabilized in the lateral Cephalogram unit (Planmeca, ProMax, Helsinki-Finland) using Cephalostat. With the position of the patients with their head oriented at 90 degree angle to the X-Ray beam at a distance of 5ft from the tube. The jaws were in maximum intercuspation, tip of the tongue behind the upper incisor teeth and lips in relaxed position. The receptor (CR, Konica Minolta medical imaging, USA) was placed 15 inches from the head. This is a standard under which all cephalometric radiographs are taken. It ensures that radiographs, taken in different times, are directly comparable.

Radiographic exposures were 60-80 Kvp, 10-15 mA, and 16-32 sec, and repeated for each case in three occasions.

The radiographs were processed in laser readout processor special for mentioned CR system. PACS. A DICOM system used for saving and transferring the images.

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)

入排标准

年龄范围
18 Years 至 28 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients need lefort 1 maxillary advancement more than 8 mm and have presurgical orthodontic preparation

排除标准

  • patients with cleft lip and alveolar cleft ,traumatic patients ,patients with previous orthognathic surgery in the maxilla and edentulous patients

研究组 & 干预措施

distraction osteogenesis

Placebo Comparator

treatment of maxillary deficiency was done just by distraction osteogenesis and no mini plate was used after removal of distractor

distraction osteogenesis+ mini plate

Active Comparator

treatment of maxillary deficiency was done just by distraction osteogenesis and after removal of distractor 4 mini plate L shaped was used after removal of distractor as an intervention

干预措施: mini plate (Device)

结局指标

主要结局

"A point" of lateral cephalometry X-ray

时间窗: 2 years after finishing the distraction

"A point" is used to determine the horizontal and vertical relapse

次要结局

  • occlusal plane(2 years after distraction is finished)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Reza Tabrizi

Assistant professor of oral and maxillofacial surgery

Shiraz University of Medical Sciences

研究点 (1)

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