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CTRI Number  CTRI/2018/02/012260 [Registered on: 28/02/2018] Trial Registered Retrospectively
Last Modified On: 01/03/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two medicines to check their effects on pain after repair of lower jaw breakage. 
Scientific Title of Study   Triple blind randomised control trial of two different treatment analgesic regimens following open reduction and internal fixation of mandibular fractures. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sahana M S 
Designation  Postgraduate trainee 
Affiliation  SDM College of Dental Sciences and Hospital 
Address  Room no.3, Department of oral and maxillofacial surgery, SDM Craniofacial Surgery and Research Centre SDM College of Dental Sciences and Hospital Sattur Dharwad

Dharwad
KARNATAKA
580009
India 
Phone  9480673960  
Fax    
Email  mesahana03@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr K Gopalkrishnan 
Designation  MDS FDSRCS 
Affiliation  SDM College of Dental Sciences and Hospital 
Address  Room no.3, Department of oral and maxillofacial surgery, SDM Craniofacial Surgery and Research Centre SDM College of Dental Sciences and Hospital Sattur Dharwad

Dharwad
KARNATAKA
580009
India 
Phone  9886329992  
Fax    
Email  gops15@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr K Gopalkrishnan 
Designation  MDS FDSRCS 
Affiliation  SDM College of Dental Sciences and Hospital 
Address  Room no.3, Department of oral and maxillofacial surgery, SDM Craniofacial Surgery and Research Centre SDM College of Dental Sciences and Hospital Sattur Dharwad

Dharwad
KARNATAKA
580009
India 
Phone  9886329992  
Fax    
Email  gops15@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  SDM College of Dental Sciences and Hospital 
Address  SDM Craniofacial Surgery and Research Centre SDM College of Dental Sciences Sattur Dharwad 
Type of Sponsor  Other [Private Dental College- SDM College of Dental Sciences and Hospital] 
 
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 Sahana M S  SDM College of Dental Sciences and Hospital  Room no.3,Department of oral and maxillofacial surgery,SDM Craniofacial Surgery and Research Centre
Dharwad
KARNATAKA 		 9480673960

mesahana03@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SDM College of Dental Sciences and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients who reported with mandibular fracture,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Group 1: received Piroxicam   Piroxicam is a Non steroidal anti-inflammatory drug Dose-20mg Route-oral twice a day for 5 days 
Comparator Agent  Group 2: received Tramadol and Paracetamol   Tramadol is an Opiod analgesic Dose- Tramadol 37.5mg and Paracetamol 325mg Route- oral twice a day for 5 days 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  ASA I, II AND III.
Mandibular fractures not associated with any acute infection.
 
 
ExclusionCriteria 
Details  Patient with any systemic illness like cardiologic and neurologic disorders.
Patient with pathologic fractures, osteoradionecrosis, strictly non-operable cases and other facial fractures.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain  Postoperative day 1 and day 2 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/11/2015 
Date of Study Completion (India) 31/07/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The mandible is one of the most frequently fractured bones in the facial skeleton. Restoration of normal occlusion, bite function, and facial symmetry are the goals of mandibular fracture treatment. Successful treatment is also judged by the avoidance of functional limitations, including pain with mouth opening, impairment of jaw movements, or any healing complications. Postoperative pain control is an important outcome in assessing overall treatment success and patient satisfaction.High levels of acute postoperative pain have been reported to be associated with slower recovery of function and increased length of hospital stay. The availability of a wider selection of analgesics allows options that can provide better efficacy, and safer profile of adverse effects. A study of pain as an outcome after surgery ideally reports the specific type of analgesics given, uses validated pain assessments, and reports adverse effects related to the agent prescribed. Multiple oral health–related quality-of-life (QOL) instruments have been developed that are generic, organ specific, or condition specific and have been used in studies of patients who have had mandibular surgery.

Thus, this study is aimed to compare efficacy  of two analgesics in pain control following open reduction and internal fixation of mandibular fractures.

 
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