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CTRI Number  CTRI/2025/10/096040 [Registered on: 14/10/2025] Trial Registered Prospectively
Last Modified On: 13/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to find out whether using one plate or two plates is better for fixing fractures in the front part of the lower jaw. 
Scientific Title of Study   Comparative Evaluation of Outcomes of Single vs Double Miniplate Fixation in Symphysis and Parasymphysis Mandibular Fractures: A Randomized Controlled 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  Dr KUMAR MAYANK 
Designation  SENIOR RESIDENT, MCH, TRAUMA SURGERY AND CRITICAL CARE 
Affiliation  AIIMS PATNA 
Address  Room No 105 TRAUMA CENTER, AIIMS PATNA, PHULWARI SHARIF, PATNA, BIHAR

Patna
BIHAR
801507
India 
Phone  9319245162  
Fax    
Email  mayank15412@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anurag Kumar 
Designation  Associate Professor 
Affiliation  aiims patna 
Address  Room No 105, Department of Trauma Surgery and Critical care, AIIMS patna, phulwari sharif, patna, bihar, 801507

Patna
BIHAR
801507
India 
Phone  9470401680  
Fax    
Email  anurages@aiimspatna.org  
 
Details of Contact Person
Public Query  
Name  Dr kumar mayank 
Designation  senior resident much trauma surgery and critical care 
Affiliation  aiims patna 
Address  Room No 105 Department of Trauma Surgery and Critical Care,AIIMS patna, phulwari sharif, patna, bihar, 801507
Room No 105 Department of Trauma Surgery and Critical Care,AIIMS patna, phulwari sharif, patna, bihar, 801507
Patna
BIHAR
801507
India 
Phone  9319245162  
Fax    
Email  mayank15412@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Kumar Mayank 
Address  Room No 105 Department of trauma surgery and critical care, Aiims Patna, Phulwarisharif, Patna, Bihar 801507  
Type of Sponsor  Other [self] 
 
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 Kumar Mayank  AIIMS PATNA  Room No 105 Department of trauma surgery and critical care, Aiims Patna, Phulwari Sharif, Patna , Bihar 801507
Patna
BIHAR 		 9319245162

mayank15412@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee, aiims patna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S026||Fracture of mandible,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Double Miniplate fixation in symphysis and parasymphysis mandible fracture  This group will have double miniplate fixation. The duration of study will be one and half years 
Comparator Agent  Single Miniplate fixation in symphysis and parasymphysis mandible fracture  Single Miniplate fixation will be done. The duration of study will be one and half years 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  a) Patients belonging to age group of 18–65 years
b) Patients giving consent for surgery
c) Fractures treatable with open reduction and internal fixation (ORIF)
d) Patients willing to attend follow-ups 
 
ExclusionCriteria 
Details  a) Old fractures which are more than 14 days
b) Fractures associated with pathological lesions or gross comminution
c) Medically compromised or unfit for anesthesia
d) Fractures with infection at the site 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Lesser incidence of post operative complications such as wound infection/dehisence, post operative discharge, plate exposure, iatrogenic dental injuries, post operative
paraesthesia and nerve injuries in single miniplate fixation group as compared to double miniplate fixation group. 		 1 yr 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1) Lesser operative time required in single miniplate fixation as compared to double miniplate fixation group.

b) Better fracture union rate in single miniplate group as compared to two miniplate fixation group at the end of
1st week and 3 months 		 1 year 6 months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 3 
Date of First Enrollment (India)   25/10/2025 
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)   Open to Recruitment 
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  

The study “Comparative Evaluation of Outcomes of Single vs. Double Miniplate Fixation in Symphysis and Parasymphysis Mandibular Fractures: A Randomized Controlled Trial” has been approved by the Institutional Ethics Committee (IEC), AIIMS Patna. Led by Dr. Kumar Mayank, with a multidisciplinary team of guides and co-guides, it aims to address the lack of robust evidence comparing single and dual miniplate fixation in mandibular fractures. Traditionally, two miniplates following Champy’s principles have been used, but this approach increases surgical time and risks, including dental or mental nerve injury, infection, and wound dehiscence. Single high-profile miniplate fixation may provide comparable stability with fewer complications and lower costs.

This single-center, open randomized controlled trial will enroll 80 adult patients (18–65 years) presenting with symphysis or parasymphysis mandibular fractures eligible for open reduction and internal fixation. After informed consent, patients will be randomized into two groups: Group A (single 2.0 mm miniplate) and Group B (dual 2.0 mm miniplates). Preoperative NCCT with 3D reconstruction will assess fracture details. Follow-ups will occur at 1, 2, 4, 6, and 12 weeks.

Primary outcomes include operative time, wound infection or dehiscence, nerve injury or paresthesia, plate exposure, and hardware stability. Secondary outcomes include fracture union at 1 and 12 weeks, occlusion, mandibular deviation, mouth opening, pain scores, and patient-reported recovery. Statistical analysis using Jamovi software will consider p<0.05 significant.

By providing high-quality comparative data, this study aims to establish whether single miniplate fixation is as effective as dual plating while reducing complications and costs. The findings are expected to improve patient care, optimize surgical resources, and inform standardized treatment protocols, particularly in resource-limited settings such as Bihar. Ethical approval has been granted, and the study will be conducted as per ICMR and GCP guidelines.

 
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