| 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
|
|
|
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
|
|
|
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. |