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临床试验/NCT07206134
NCT07206134已完成不适用

Modified Omega Bone Plate Versus Conventional Miniplates for Fixation of Mandibular Fractures in Mental Nerve Region

Tanta University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2023年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
Pain intensity measured using Visual Analogue Scale (VAS)

研究概览

简要总结

Twelve adult patients with mandibular fractures in the mental region were enrolled and randomly divided into two equal groups. Group I received fixation using custom-designed modified omega bone plates, while Group II was treated with conventional titanium miniplates following Champy's technique. Virtual surgical planning and 3D printing technology were used to fabricate customized plates in Group I. Clinical and radiographic assessments were conducted immediately, at 1 week, 3 months, and 6 months postoperatively. Parameters evaluated included soft tissue healing, pain, facial edema, lower lip paresthesia, maximal mouth opening, occlusion, fracture stability, and hardware integrity.

详细描述

This study was conducted on twelve adult patients with mandibular fracture in mental nerve region, selected from the outpatient clinic, Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Tanta University.

The selected patients were randomly divided into two equal groups, group I (6 patients) were treated by modified omega bone plate, while group II (6 patients) were treated by 2.0 mm conventional miniplates according to Champy's principle. A comparison between the two groups was conducted.

Modified Omega bone plate is a specially-designed, 8-hole, titanium miniplate modified by adding upper struts to the Ω symbol. It has lower horizontal struts (which provides stability along the lower border) with four holes, the proximal 2 holes are round and the distal are pear shape (compression holes). Two vertical struts at the ends of the horizontal struts (which provide resistance against the torsional forces),Upper horizontal struts (which counteract the tensional forces along the alveolar border) with four holes the proximal 2 holes are round and the distal are pear shape. The omega shape of this plate helps it to adapt easily around the mental neurovascular bundle.

Preoperative evaluation of the patients was carried out by taking history and performing clinical and radiographic examinations. Clinical examination included intraoral and extraoral inspection and palpation of the fracture sites. Radiographic examination was used to determine the site, number, type of fractures and degree of displacement.

Under general anesthesia, the fracture line was exposed through an intraoral approach, and the fracture segments were reduced. In group I, fixation of the reduced segments was done with modified omega bone plate which predetermined virtually. In group II, 2conventional miniplates placed on inferior border & subapical were used to fix the fracture.

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 (Participant, Outcomes Assessor)

盲法说明

using closed envelop for participants the data will be given to outcomes assessors without defining the intervention for each group

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Patients with displaced mandibular parasymphysis or body fracture in the mental nerve region
  • •Indicated for open reduction and internal fixation (ORIF)

排除标准

  • •Patients with systemic diseases that affect bone healing
  • •Fractures with crushed mental foramen
  • •Comminuted fractures where fixation is difficult
  • •Patients with anatomical variations (e.g., bifid inferior alveolar or mental nerve), based on preoperative CT nerve tracing

研究组 & 干预措施

Modified Omega bone plate used for fixation of mandibular fractures in mental foramen region

Experimental

Reflection of vestibular flap without dissection around mental bundle and fracture reduction and fixation with 3D Modified Omega bone plate

干预措施: Modified Omega bone plate for fixation of mandibular fractures in mental foramen region (Procedure)

Conventional miniplates used for fixation of mandibular fractures in mental foramen region

Experimental

Reflection of vestibular flap and dissection around mental bundle and fracture reduction and fixation with 2 miniplates

干预措施: Conventional miniplates for fixation of mandibular fractures (Procedure)

结局指标

主要结局

Pain intensity measured using Visual Analogue Scale (VAS)

时间窗: At 1 day, 3 days, 1 week, and 1 month postoperatively

Pain will be assessed using a 10-cm Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).

次要结局

  • Neurosensory function assessed by two point discrimination test(Up to 3 months)
  • Facial edema measured using linear facial measurements(At 1 day, 3 days, 1 week)
  • Maximal Interincisal Opening (MIO)(Preoperative, and postoperative day 1, day 3, 1 week, and 1 month)
  • Occlusion Status(Postoperative 1 week and 1 month)
  • Operation Time(Intraoperative)
  • Interfragmentary Gap(1 day Postoperative)

研究者

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

Mohamed sobhie abdelhameed

Principal Investigator, Teaching Assistant of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tanta University

Tanta University

研究点 (1)

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