跳至主要内容
临床试验/CTRI/2025/07/091589
CTRI/2025/07/091589招募中Unknown

Comparative evaluation and effectiveness of self-tapping screws and drill-free titanium mini screws for internal fixation of facial trauma in maxillofacial surgery: a randomized control trial

未提供1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月12日最近更新:

试验速览

阶段
Unknown
状态
招募中
入组人数
60
试验地点
1
主要终点
To evaluate and compare the effectiveness of self-drilling screws over self-tapping screws for internal fixation in maxillofacial fractures

研究概览

简要总结

The landscape of maxillofacial trauma has undergone a significant transformation in recent decades, driven by rapid urbanization, technological advancement, and shifting societal patterns. Epidemiological data reflect a consistent rise in the incidence of facial injuries, especially in developing urban centres, with a marked increase over the past decade. (1) This growing burden presents a major challenge in contemporary surgical practice, demanding more refined and efficient treatment strategies. Contributing factors include the surge in high-speed vehicular traffic, expanding city infrastructure, poor road conditions, and increased exposure to high-risk environments. Road traffic accidents, particularly in underdeveloped and overcrowded cities, have emerged as a predominant cause of facial trauma, often compounded by alcohol consumption. However, trauma also arises from other sources such as interpersonal violence, sports injuries, occupational hazards, and accidental falls, contributing to a multifactorial and complex injury profile.(3)(4)

Beyond the immediate physical damage, maxillofacial trauma often leads to profound psychological and social consequences. Patients suffering from disfigurement or impaired oral and facial function may experience long-term challenges related to self-image, social interactions, and professional capabilities. These outcomes underscore the critical importance of timely and effective surgical intervention aimed at restoring both aesthetics and function. (5)  The principal goal in managing such trauma is to return the facial structures as close as possible to their pre-injury state. This includes not only the reconstruction of facial contours but also the restoration of key functions such as mastication, speech, and jaw mobility. The success of these objectives depends heavily on the fixation methods and materials employed during surgery. (6)

The introduction of internal fixation using titanium mini screws revolutionized maxillofacial surgery by offering superior stability and more predictable healing compared to traditional wire fixation. Modern internal fixation systems now primarily utilize two types of titanium mini screws: self-tapping screws (STS) and drill-free or self-drilling screws (DFS). STS require a pre-drilled pilot hole prior to insertion, which, although effective, increases operative time and introduces potential risks such as thermal bone injury. In contrast, DFS are designed to be inserted directly into the bone without pre-drilling, potentially reducing operative time and minimizing trauma to surrounding tissues. (9)

Emerging studies have begun to evaluate the comparative performance of these two screw types. Research suggests that DFS may offer advantages in terms of surgical efficiency and reduced bone trauma. (10) However, concerns remain regarding their mechanical stability and clinical reliability over time. Biomechanical evaluations comparing parameters such as insertion torque, pull-out resistance, and performance under different loading conditions have provided valuable insights, though a comprehensive clinical comparison is still lacking.

In light of these considerations, this article aims to conduct a comparative evaluation of STS and DFS in the internal fixation of facial fractures. By analysing  parameters such as ease of insertion, intraoperative plate and fracture segment stability, and hardware-related complications, the study intends to offer clinically relevant data that could influence surgical decision-making. As the field of maxillofacial trauma surgery continues to evolve, such evidence-based investigations are essential to refine current practices and enhance patient care outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patient with simple fracture indicated for ORIF Patients above the age of 18 years and both genders will be included Patients with systemic diseases like Hypertension, Diabetes Mellitus, etc., which are under control.

排除标准

  • Patient with comminuted fracture Patients above the age of 60 Pregnant or lactating females Patients undergoing long term corticosteroid or bisphosphonate therapy Patients not willing to sign informed consents.

结局指标

主要结局

To evaluate and compare the effectiveness of self-drilling screws over self-tapping screws for internal fixation in maxillofacial fractures

时间窗: the primary outcomes will be evaluated intraoperatively that is at the time of surgery itself

次要结局

  • To evaluate the duration of internal fixation(To evaluate the ease of insertion)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Teena Oommen

VSPMs Ranjeet Deshmukh Dental College and Research Centre, Nagpur

研究点 (1)

Loading locations...

相似试验