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CTRI Number  CTRI/2025/05/086773 [Registered on: 13/05/2025] Trial Registered Prospectively
Last Modified On: 09/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing Two Methods to Stabilize Broken Jaw Bones: Traditional Wire Braces vs. Screw-Fixed Braces 
Scientific Title of Study   A Comparative Study Of Efficacy Between Erichs Arch Bar And Self Drilling Screw Retained Hybrid Arch Bar In Maxillofacial Trauma  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Binshi Biju 
Designation  Post Graduate 
Affiliation  Kamineni Institute of Dental Sciences 
Address  Department of Oral and Maxillofacial Surgery Ground floor Room Number 3 Sreepuram Narketpally

Nalgonda
TELANGANA
508254
India 
Phone  9063544398  
Fax    
Email  binshibiju964@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr B Pavan Kumar 
Designation  Professor and Head of the Department 
Affiliation  Kamineni Institute of Dental Sciences 
Address  Department of Oral and Maxillofacial Surgery Ground floor Room Number 3 Sreepuram Narketpally

Nalgonda
TELANGANA
508254
India 
Phone  9849023200  
Fax    
Email  pavankumarbatchu40@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr B Pavan Kumar 
Designation  Professor and Head of the Department 
Affiliation  Kamineni Institute of Dental Sciences 
Address  Department of Oral and Maxillofacial Surgery Ground floor Room Number 3 Sreepuram Narketpally


TELANGANA
508254
India 
Phone  9849023200  
Fax    
Email  pavankumarbatchu40@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  SELF 
Address  Kamineni Institute of Dental Sciences Department of Oral and Maxillofacial Surgery Ground floor Room Number 3 Sreepura Narketpally Nalgonda Telangana 508254 India  
Type of Sponsor  Other [Sslf] 
 
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 
Dr Binshi Biju  Kamineni Institute of Dental Sciences  Department of Oral and Maxillofacial Surgery Ground Floor Room Number three Sreepuram Narketpally Nalgonda Telangana
Nalgonda
TELANGANA 		 9063544398

binshibiju964@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S024||Fracture of malar, maxillary and zygoma bones, (2) ICD-10 Condition: S026||Fracture of mandible,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  To evaluate and compare the effectiveness of self drilling screw retained hybrid arch bar and Erichs arch bar for intermaxillary fixation in the management of maxillofacial trauma.   GROUP I(TEST) Number of patient 31:Screw retained hybrid arch bar GROUP II (CONTROL)Number of patient 31: Erichs arch bar  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Participants aged 18-65 years requiring arch bar fixation.
Oral maxillofacial trauma who requires arch bar fixation.
Participants who are willing to give consent for the study.
 
 
ExclusionCriteria 
Details  Participants aged below 18 years and above 65 years.
Patients with the conditions where arch bar fixation is contraindicated.
Participants who are not willing to give informed and written consent for the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess and compare the occlusal stability provided by self drilling screw retained hybrid arch bar and Erich’s arch bar.
To assess and compare the time taken for the placement and removal of self drilling screw retained hybrid arch bar and Erich’s arch bar.
To assess and compare the injury to operator and assistant.
To assess intra operative and post operative soft tissue injury to the patient.
To assess and compare the incidence of glove tear.
 		 Baseline, 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To see the wire and screw loosening  Baseline and after 4 weeks 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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   Phase 2 
Date of First Enrollment (India)   30/07/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   Erich’s arch bar has traditionally been used for intermaxillary fixation (IMF) in maxillofacial trauma. However, it presents risks like wire prick injuries, glove tears, and increased operative time. The screw-retained hybrid arch bar is proposed as a safer and more efficient alternative.
AIM OF THE STUDY To evaluate and compare the effectiveness of Erich’s arch bar and self-drilling screw retained hybrid arch bar for intermaxillary fixation in the management of maxillofacial trauma.
OBJECTIVES OF STUDY Compare occlusal stability 
Compare placement and removal times
Evaluate operator and assistant injuries
Assess patient soft tissue injury and glove tear incidence
METHODOLOGY 
Inclusion: Patients aged 18–65 with maxillofacial trauma requiring IMF.
Exclusion: Patients outside the age range, those unwilling to consent, or with contraindications for arch bar use.
Assessment Parameters:
Preoperative: Occlusion, tooth vitality, radiological evaluation
Intraoperative: Time, ergonomics, glove/wire injuries
Postoperative: Removal time, tooth morbidity, screw/wire loosening, soft tissue status
After the placement of arch bars in both groups , parameters are assessed such as time of placement, removal, occlusal stability, operator and assistant injury, wire prick injury, soft tissue injury.
 
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