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CTRI Number  CTRI/2024/07/071583 [Registered on: 30/07/2024] Trial Registered Prospectively
Last Modified On: 29/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing 3D Printed Splints to Traditional Methods for Cheekbone Fractures Treatment: Which Works Better? 
Scientific Title of Study   Comparative Analysis of 3D Printed Reduction Splints vs Conventional Methods in Zygomaticomaxillary Complex Fractures: Assessing Anatomical Reduction and Clinical Outcomes 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  POOJALEKSHMI M B 
Designation  JUNIOR RESIDENT (ACADEMIC) 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES RAIPUR 
Address  Division of Oral and Maxillofacial Surgery, Department of Dentistry, All India Institute of Medical Sciences,Raipur G.E Road, Tatibandh, Raipur, Chattisgarh

Raipur
CHHATTISGARH
492099
India 
Phone  8606528287  
Fax    
Email  poojalekshmiad@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SANTHOSH RAO 
Designation  PROFESSOR 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES RAIPUR 
Address  Faculty Room, Division of Oral and Maxillofacial Surgery, Department of Dentistry All India Institute of Medical Sciences, Raipur G.E Road, Tatibandh Raipur Chattisgarh

Raipur
CHHATTISGARH
492099
India 
Phone  9981525599  
Fax    
Email  santhosh@aiimsraipur.edu.in  
 
Details of Contact Person
Public Query  
Name  POOJALEKSHMI M B 
Designation  JUNIOR RESIDENT (ACADEMIC) 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES RAIPUR 
Address  Division of Oral and Maxillofacial Surgery, Department of Dentistry, All India Institute of Medical Sciences, Raipur G.E Road, Tatibandh Raipur Chattisgarh

Raipur
CHHATTISGARH
492099
India 
Phone  8606528287  
Fax    
Email  poojalekshmiad@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Raipur, G.E Road, Tatibandh, Raipur, Chattisgarh. PIN CODE: 492099 
 
Primary Sponsor  
Name  Dr Poojalekshmi M B 
Address  Division of Oral and Maxillofacial Surgery, Department of Dentistry AIIMS RAIPUR Tatibandh, Raipur Chattisgarh 
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 Poojalekshmi M B  All India Institute of Medical Sciences, Raipur  Division of Oral and Maxillofacial Surgery Department of Dentistry All India Institute of Medical Sciences, Raipur
Raipur
CHHATTISGARH 		 8606528287

poojalekshmiad@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee अखिल भारतीय आयुर्वज्ञि ान संस्थान , रायपुर (छत्तीसगढ़) All India Institute of Medical Sciences, Raipur(Chhattisgarh)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Application of a 3D printed reduction splint fabricated through virtual surgical planning for Zygomaticomaxillary Complex Fracture reduction  NCCT of the patient is collected and converted into DICOM images and Collect data related to VSP, including digital models, plans, and specifications generated through Virtual surgical planning(VSP) software. VSP is done by mirroring the position based on the contralateral side and fabrication of 3D printed reduction splints for affected ZMC fracture patients and these reduction splints are used intraoperatively for reduction for fractures and total time taken for the reduction is noted. Duration is only for intraoperative period 
Comparator Agent  Conventional reduction methods based on standard clinical practices for reduction of Zygomaticomaxillary complex fractures  NCCT of the patient is collected and proper diagnosis and treatment plan is made on standard clinical practices. The fracture reduction is using standard conventional method intraoperatively and reduction time is noted. Post operatively NCCT is done and compare for the accuracy of the reduction. Duration is only for intraoperative period. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  i. Patients diagnosed with unilateral Zygomaticomaxillary
Complex (ZMC) fractures confirmed through clinical
examination and imaging (CT scans).
ii. Adults aged 15 to 65 years.
iii. Willingness to provide informed consent for participation in
the study.
iv. Patients within 1 month from the occurrence of ZMC fracture
v. Absence of prior history of zygomaticomaxillary complex
fractures. 
 
ExclusionCriteria 
Details  i. Patients with bilateral Zygomaticomaxillary Complex
fractures.
ii. Inability or unwillingness to complywith studyrequirements,
including scheduled follow-up visits.
iii. Pregnant individuals due to potential risks associated with
imaging procedures and treatment
iv. Inability to understand or communicate effectively in the
language used for study assessments.
v. Severe medical conditions that may impact the ability to
undergo surgery or participate in the study.
vi. Syndromes with malar involvement:
Eg., Malar hypoplasia in Treacher-Collins Syndrome 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Precision of anatomical reduction assessed by radiographs, measuring orbital
volume and linear dimensions.
 		 Preoperatively, Immediate post operatively, One week post operatively, One month post operatively and Three months post operatively
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Facialsymmetry and aesthetic outcomes assessed through clinical photography
in both frontal and supracranial oblique view.
2. Patient’s satisfaction in terms of facial aesthetics by means of aesthetic severity
score.
3. Time taken for reduction of the fracture 		 preoperative assessment, immediate postoperative assessment and late post operative assessment 
1. Facialsymmetry and aesthetic outcomes assessed through clinical photography
in both frontal and supracranial oblique view.
2. Patient’s satisfaction in terms of facial aesthetics by means of aesthetic severity
score.
3. Time taken for reduction of the fracture 		 preoperative assessment, immediate postoperative assessment and late post operative assessment 
 
Target Sample Size   Total Sample Size="16"
Sample Size from India="16" 
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 4 
Date of First Enrollment (India)   12/08/2024 
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   “Comparative Analysis of 3D Printed Reduction Splints vs Conventional Methods in Zygomaticomaxillary Complex Fractures: Assessing Anatomical Reduction and Clinical Outcomes -  A Pilot Randomised controlled trial is a double blinded clinical trial provisionally approved by Institute Ethics Committee, yet to start with recruiting participants. The primary objective of my study is “To compare the precision of anatomical reduction in Zygomaticomaxillary Complex fractures between patients treated with a 3D printed reduction splint and those treated with conventional reduction methods” for that will be utilizing the benefits of virtual surgical planning in the treatment planning and procedure of ZMC fractures for providing the best results for the patient. Assessing the effectiveness of this technology in zygomaticomaxillary complex fractures can contribute to advancing surgical techniques and patient care. Improved anatomical reduction and stability may lead to better clinical outcomes, including reduced complications, improved functionality, and enhanced aesthetic results. Positive outcomes from this study could influence and shape clinical guidelines, encouraging the adoption of 3D printing and virtual surgical planning in managing facial fractures.  
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