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CTRI Number  CTRI/2024/05/066791 [Registered on: 06/05/2024] Trial Registered Prospectively
Last Modified On: 27/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   A clinical trial to study the the New hinge-based miniplates for Maxillofacial fractures 
Scientific Title of Study   Evaluation of the efficacy of the neoteric all-rounder Hinge plating system in maxillofacial Fractures: An in-vivo study 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Varsha S 
Designation  Post Graduate 
Affiliation  Sri Siddhartha Academy of Higher Education 
Address  No. 2, Department of Oral and Maxillofacial Surgery, Sri Siddhartha Dental College and Hospital,Agalakote, BH Road, Tumkur

Tumkur
KARNATAKA
572107
India 
Phone  9886994175  
Fax    
Email  varsha.subramanyam96@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mahesh Kumar R 
Designation  Professor and HOD 
Affiliation  Sri Siddhartha Academy of Higher Education 
Address  No. 2, Department of Oral and Maxillofacial Surgery, Sri siddhartha Dental College and Hospital, Agalakote, B H Road,
,
Tumkur
KARNATAKA
572107
India 
Phone  9845417365  
Fax    
Email  mahu017@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mahesh Kumar R 
Designation  Professor and HOD 
Affiliation  Sri Siddhartha Academy of Higher Education 
Address  No. 2, Department of Oral and Maxillofacial Surgery, Sri siddhartha Dental College and Hospital, Agalakote, B H Road,
,
Tumkur
KARNATAKA
572107
India 
Phone  9845417365  
Fax    
Email  mahu017@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Varsha S 
Address  No.2, Department of Oral and Maxillofacial Surgery, Sri siddhartha Dental College, Agalakote, BH Road, Tumkur-572107 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
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 Varsha S  Sri Siddhartha Medical College and Hospital  Room no. 2, Department of Oral and Maxillofacial Surgery
Tumkur
KARNATAKA 		 9886994175

varsha.subramanyam96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sri Siddhartha Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: V00-Y99||External causes of morbidity,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  All Rounder Hinge Plating System  A Maxillofacial Titanium Plating system With a novel design that enables it to be used in multiples sites of the face. The novel plate will be used to fix complicated maxillofacial fractures post reduction and observed at regular intervals over a period of 6 months. 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients with Complicated Maxillofacial fractures of the middle and lower one third of the face
2.Patients who are certified fit for surgery by physician (based on ASA classification)
3.Patients’ cooperative to Clinical and radiological follow up for the study duration
 
 
ExclusionCriteria 
Details  1. Patients not fit for surgical procedures (based on ASA classification)
2. Grade 3 Atrophic mandible (based on Luhr classification)
3. Pre- traumatic Functional deficit 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Fracture stability dental occlusion  2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
clinical function
aesthetics
bone healing 		 6 months 
 
Target Sample Size   Total Sample Size="19"
Sample Size from India="19" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   17/05/2024 
Date of Study Completion (India) 09/05/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Will be available at later date

  6. For how long will this data be available start date provided 07-07-2023 and end date provided 30-11-2024?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 Treatment of Maxillofacial fractures require specific plating systems based on the Bony morphology, type & site of fracture. The need for accurate and efficient treatment has led to the introduction of various plating systems based on material, size and shape. My study is based on the idea of developing one plating system that can be modified chairside into various shapes and at most sites. It will be a breakthrough for health professionals and the field of Oral and Maxillofacial surgery for the management of facial fractures. 
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