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临床试验/NCT03839368
NCT03839368Unknown不适用

Stability of Angle Fracture Fixation With (K) Shaped Titanium Miniplates Versus Two Conventional Miniplates: Randomized Clinical Trial

Cairo University0 个研究点目标入组 12 人开始时间: 2020年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
12
主要终点
Stability of angle fracture fixation

研究概览

简要总结

In patients with angle fracture , will the (K) shaped titanium miniplates provide more stable fixation than two conventional miniplates? Many studies have been conducted to compare between different techniques of fixation used in angle fracture fixation. The driving force behind this study was to design a new plate that would overcome the disadvantages of the other plating techniques but has the advantages & simplicity of the Champy technique (simple intraoral approach and few major complications). This new miniplate gives more biomechanical stability than the conventional Champy plate. More over the placement of a 3D miniplate or two separate miniplates for fixing angle fractures is more difficult and mostly will require a transbuccal approach , with increased surgical trauma, longer operation time unlike the new plate that could provide the clinician with a simple and reliable solution.

详细描述

In the past two decades, rigid internal fixation with miniplate has become the standard treatment modality in the management of mandibular fracture.

The optimal management of mandibular angle fractures remains controversial, thus continuous experimental & clinical studies are being conducted to determine the best miniplate design which will provide the best postoperative stability & resistance to mechanical function.

Since Michelet et al.& Champy et al. recommended the use of a single (4-6 holes) monocortical plate , it become an acceptable method for angle fractures fixation.

Several surgeons have documented low complication rates with (Champy technique).But, according to the most recent experimental & clinical studies, the stability provided by the miniplate fixation has become a point of debate among surgeons.Many researchers have argued that internal fixation with a passive miniplate along the external oblique line, following Champy's ideal osteosynthesis line principle, produces a tension effect that may yield a failure of osteosynthesis & gap at inferior border of the mandible.And that pushed researches to conduct more studies to evaluate many plate & screw systems and even suggest new designs for better stable postoperative results.

In 2014, B.T.Suer et al, designed a new noncompression 3D miniplates , basically it has one straight section and two lateral extensions. The straight section of this new design, which has four holes, was adapted to the superior border of the external oblique ridge & provides similar advantages to the Champy technique (an intraoral approach, a single miniplate, & the use of monocortical screws) .And the two lateral extensions, with one hole each, were then bent over to adapt to the buccal cortex of the ascending ramus along the external oblique ridge to resist lateral & torsional forces.

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
15 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with unilateral angle fracture.
  • Patients free from any systemic disease & bone metabolism diseases.
  • No sex predilection
  • Age range ( 15-70)

排除标准

  • Comminuted fragmented & infected angle fractures.
  • Bilateral angle fracture.
  • Systemic diseases.
  • bone metabolism diseases

研究组 & 干预措施

K plate

Experimental

fixation of angle fracture using K plate versus two miniplates

干预措施: fixation of angle fracture (Procedure)

Conventional two miniplates

Active Comparator

fixation of angle fracture using K plate versus two miniplates

干预措施: fixation of angle fracture (Procedure)

结局指标

主要结局

Stability of angle fracture fixation

时间窗: 3 months

Inter-ramus distance (fixed position at the lingual), inter-mental distance will be obtained from the immediate postoperative facial bone CT \& after 3 months. Comparison between the 2 records will be done to assess the stability of fixation technique. Bone density will be measured by Hounsfield unit at fracture site immediate postoperative \& after 3 months using F.B.CT.

次要结局

未报告次要终点

研究者

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

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

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