FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/07/043920 [Registered on: 12/07/2022] Trial Registered Prospectively
Last Modified On: 10/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial comparing one load bearing fixation and one load sharing fixation versus two load sharing fixation in double mandibular fracture 
Scientific Title of Study   ‘‘Comparative study to evaluate the occurrence of nonunion/malunion in the double mandibular fracture patients who are treated with one load bearing fixation in anterior fracture and one load sharing fixation in posterior fracture vs two load sharing fixation – Randomized controlled trial”  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  KISHORE M S  
Designation  Junior Resident (Academic) 
Affiliation  CDER,AIIMS, new Delhi 
Address  Department of Oral and Maxillofacial Surgery, CDER, AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone  9790903321  
Fax    
Email  mskishoremalaiselvam@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ongkila Bhutia 
Designation  Professor 
Affiliation  CDER,AIIMS, new Delhi 
Address  Department of Oral and Maxillofacial Surgery, CDER, AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone  9313349564  
Fax    
Email  dr.ongkila@gmail.com  
 
Details of Contact Person
Public Query
 
Name  KISHORE M S  
Designation  Junior Resident (Academic) 
Affiliation  CDER,AIIMS, new Delhi 
Address  Department of Oral and Maxillofacial Surgery, CDER, AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone  9790903321  
Fax    
Email  mskishoremalaiselvam@gmail.com  
 
Source of Monetary or Material Support  
Department of Oral and Maxillofacial Surgery, CDER, AIIMS, New Delhi 
 
Primary Sponsor  
Name  KISHORE M S 
Address  Department of Oral and Maxillofacial Surgery,CDER, AIIMS, New Delhi-110029 
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 M S Kishore  CDER,AIIMS  Room no 115, Department of Oral and Maxillofacial Surgery, CDER, AIIMS, New Delhi-110029
New Delhi
DELHI 
9790903321

mskishoremalaiselvam@gamil.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Load sharing fixation and load bearing fixation   Miniplate and Reconstruction plate in double mandibular fracture patient. Patients will be reviewed after 10 weeks of placement for evaluating malunion or non union 
Comparator Agent  two load sharing fixation  Two miniplates in double mandibular fracture patients. Patients will be reviewed after 10 weeks of placement for evaluating malunion or nonunion 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients with double mandibular fracture 
 
ExclusionCriteria 
Details  Edentulous patients with atrophic mandible, Patients with condyle, coronoid or ramus fracture, Patients having fracture with bone loss who need bone graft, Infected mandibular fractures, Comminuted mandibular fractures,Patients with old mandibular fractures who requires surgery for residual deformities
>8 wecks from time of trauma ).
7. Pan facial trauma/associated maxillary fracture requiring postoperative I 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Non-union   non-union will be assessed after 10 weeks of placement 
 
Secondary Outcome  
Outcome  TimePoints 
Pain and infection  after 10 weeks of placement of the plates 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   15/07/2022 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is a clinical trial to compare and evaluate the occurrence of nonunion  and malunion in double mandibular fracture  patients who are treated with one load bearing fixation in anterior fracture and one load sharing fixation in posterior fracture vs two load sharing fixation. The primary outcome measure will be occurrence of nonunion at the time of followup.
 
Close