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临床试验/NCT03692260
NCT03692260Unknown不适用

Interfragmentary Gap Following Cannulated Headless Herbert Screw Insertion Using Customized 3-D Surgical Templates Versus Titanium Plate In Reduction & Fixation of Unilateral Minimally Displaced Mandibular Angle Fracture. RCT

Cairo University0 个研究点目标入组 20 人开始时间: 2018年10月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
主要终点
inertfragmentary gap

研究概览

简要总结

interfragmentary gap measurement using Herbert cannulated headless screw using a 3D surgical customized template versus titanuim plate

详细描述

  • Intervention for each group
  1. Diagnosis
  • for group I and II According to inclusion and exclusion criteria, patients are selected after a comprehensive clinical and radiographic examination and understanding of participant s chief complains.
  • Inspection for the soft tissue laceration, edema, ecchymosis, hemorrhage, cerebrospinal fluid leakage, gingival lacerations, mandible contour deformity, facial asymmetry and the other facial bones bilateral palpation starting from the condylar region descending towards the posterior border of the mandible to look for any tenderness, step deformities or crepitus. Examination of the integrity of the neurosensory and motor function of the injured area.
  • Checking the amount of occlusal discrepancy with complete and comprehensive examination of the dentition.
  • Mandibular movements will also be checked with emphasis on maximal Interincisal opening and midline shift in opening and closing positions.
  1. Surgical planning Group I :participants will be treated using Herbert headless cannulated screw(Zimmer® Herbert™ ,united states of America )Cannulated Bone Screw) using 3d template GroupII :patients are treated using titanium plates (4 or 6 holes according to each case) orthomed ,6th of October,Egypt)
  2. Intra-operative procedures:

-All of the participants will be treated under general anaesthesia using nasal intubation

  • The occlusion was secured with temporary IMF and the fracture line was exposed and manually reduced.
  • Infiltration Local anesthesia with vasoconstrictor will be injected intraorally at the incision site for hemostatic purposes and pain control.
  • Scrubbing and draping of the patient will be carried out in a standard fashion.
  • An intraoral incision to expose the fracture line. Dissection and reflection to reach the bone For the intervention group planning using the ct software to produce a guiding template of the mandible in the normal position for the insertion of the Herbert screw.

Reduction of the fracture -Fixation of the fractured segments through Herbert screw using the 3D template fabricated by Plastycad 3diemme Italy(group I), or by using titanium the plate (groupII)

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 (Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patient age between 20 to 45
  • Patients with minimally displaced angular fracture
  • Patients free from any systemic disease that delay bone healing
  • Patients free from any metabolic bone disease delaying the healing
  • Patients who approved to be included in the trial and signed the informed consent.

排除标准

  • .Patients receiving chemotherapy or radiotherapy "due to the risk of low bone quality and healing.(Hopewell, 2003)
  • Patients who refused to be included in the trial

研究组 & 干预措施

control group

No Intervention

titanium plate

intervention group

Active Comparator

3D stent in Herbert screw insertion vs titanium plate

干预措施: 3D stent in Herbert screw insertion vs titanium plate (Procedure)

结局指标

主要结局

inertfragmentary gap

时间窗: 3 months as after that time bone remodeling will happen and measuring the interfragmentary gap will be inaccurate

will be measured using the panoramic xray film on the panoramic radiograph a line was drawn along the fracture and it was divided into 3 equal parts in mm. Perpendicular lines were projected onto the fracture line for reproducible measure points. Measurements of the fracture gap were conducted on these 4 defined points

次要结局

  • nerve sensitivity(3 months)
  • maximum incisal opening(3 months)
  • pain relief(3 months)

研究者

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

Nevine Alaa Eldine

assistant lecturer

Cairo University

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