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CTRI Number  CTRI/2025/07/091589 [Registered on: 24/07/2025] Trial Registered Prospectively
Last Modified On: 24/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   self tapping screw versus drill free screws in patients with facial fractures 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Teena Oommen 
Designation  Junior Resident 
Affiliation  VSPMs Ranjeet Deshmukh Dental College and Research Centre, Nagpur 
Address  VSPMSs Ranjeet Deshmukh Dental College and Research Centre Department of Oral and Maxillofacial Surgery

Nagpur
MAHARASHTRA
440019
India 
Phone  9650254399  
Fax    
Email  teenaoommen@ymail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ramakrishna Shenoi 
Designation  Professor 
Affiliation  VSPMs Ranjeet Deshmukh Dental College and Research Centre, Nagpur 
Address  Department of Oral and Maxillofacial Surgery
Department of Oral and Maxillofacial Surgery
Nagpur
MAHARASHTRA
440019
India 
Phone  9822220505  
Fax    
Email  ramakrishna.shenoi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Teena Oommen 
Designation  Junior Resident 
Affiliation  VSPMs Ranjeet Deshmukh Dental College and Research Centre, Nagpur 
Address  Department of Oral and maxillofacial Surgery
Department of Oral and Maxillofacial Surgery
Nagpur
MAHARASHTRA
440019
India 
Phone  09650254399  
Fax    
Email  teenaoommen@ymail.com  
 
Source of Monetary or Material Support  
VSPMs Ranjeet Deshmukh Dental College and Research Centre, Nagpur Department of Oral And Maxillofacial Surgery 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Teena Oommen  VSPMs Ranjeet Deshmukh Dental College and Research Centre  Department of Oral and Maxillofacial Surgery
Nagpur
MAHARASHTRA 
9650254399

teenaoommen@ymail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
VSPM Dental College & Research Centre, Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S029||Fracture of unspecified skull andfacial bones,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Drill Free Screws  Drill Free Screws can be drilled directly onto the bone hence avaiding the pre drilling phase 
Intervention  Self Tapping Screws  these screws require a pilot drill before fixation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the effectiveness of self-drilling screws over self-tapping screws for internal fixation in maxillofacial fractures  the primary outcomes will be evaluated intraoperatively that is at the time of surgery itself 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the duration of internal fixation
To evaluate the ease of insertion
To evaluate intra operative stability of plate
To evaluate intra operative fracture segment
To evaluate hardware failures
 
the secondary outcomes will be evaluated intraoperatively that is at the time of surgery itself 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   12/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
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