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CTRI Number  CTRI/2024/04/065585 [Registered on: 12/04/2024] Trial Registered Prospectively
Last Modified On: 10/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative Study Between Diclofenac And Ketoprofen Transdermal Patch For Pain Management In Patients Undergoing Minor Oral Surgical Procedures  
Scientific Title of Study   Comparison Between Efficacy Of Transdermal Diclofenac And Ketoprofen Patch For Pain Management In Patients Undergoing Minor Oral Surgical Procedures. 
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 Amir Sohail 
Designation  Post Graduate Student 
Affiliation  Government Dental College and Research Institute, Bangalore 
Address  Room Number 2B, Department of Oral And Maxillofacial Surgery, Government Dental College And Research Institute, Bangalore.

Bangalore
KARNATAKA
560002
India 
Phone  7204678825  
Fax    
Email  mdamirsohail44@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Hemamythily P 
Designation  Associate Professor 
Affiliation  Government Dental College and Research Institute, Bangalore 
Address  Room Number 2B,Department of Oral And Maxillofacial Surgery, Government Dental College And Research Institute, Bangalore.

Bangalore
KARNATAKA
560002
India 
Phone  8618429628  
Fax    
Email  h_mythily@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Girish B Giraddi 
Designation  Professor and Head of the Department 
Affiliation  Government Dental College and Research Institute, Bangalore 
Address  Room Number 2B, Department of Oral And Maxillofacial Surgery, Government Dental College And Research Institute Bangalore.

Bangalore
KARNATAKA
560002
India 
Phone  9740098199  
Fax    
Email  girishgiraddi@gmail.com  
 
Source of Monetary or Material Support  
Government Dental College And Research Institute, Victoria Hospital Campus, K R Market, Bangalore, Karnataka, India 560002 
 
Primary Sponsor  
Name  Dr Amir Sohail 
Address  Dept of OMFS, Government Dental College and Research Institute, Bangalore 
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 Amir sohail  Government Dental College and Research Institute, K R Market, Bangalore  Room Number 2B, Department Of Oral And Maxillofacial Surgery
Bangalore
KARNATAKA 
7204678825

mdamirsohail44@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Government Dental College And Research Institute, Bangalore  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  Tablet Aceclofenac+Paracetamol  Aceclofenac 100mg + Paracetamol 325mg Orally, Twice A Day After Food For 5 Days 
Comparator Agent  Transdermal Diclofenac Patch  Patch Containing Diclofenac 100mg, To be Applied Transdermally, Once Daily for One Day Post Operatively. 
Comparator Agent  Transdermal Ketoprofen Patch  Patch Containing Ketoprofen 30mg, To be Applied Transdermally, Once Daily for One Day Post Operatively. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  ASA 1 Category Patients
Transalveolar Extractions
Alveoloplasty Procedures
Enuleation Procedures
Soft Tissue Biopsies 
 
ExclusionCriteria 
Details  Subjects Allergic To Diclofenac, Ketoprofen Or Any Other NSAIDs 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
pain measurement using Visual analogue scale and Wong Bakers scale  pain measurement using Visual analogue scale and Wong Bakers scale at 0,6,12,24 and 48 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluating The Efficacy Of Trandsdermal Diclofenac And Ketoprofen Patch In Pain Management Using Visual Analogue Scale And Wong Bakers Scale  Pain Measurement At The Interval Of 0,6,12,24,48 Hours 
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
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)   24/04/2024 
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="1" 
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  
Post operative pain control is a significant aspect in patient management following an oral and maxillofacial surgical procedure. A clinician’s inadequacy in providing adequate analgesia to relieve post operative pain may lead to patient’s physical as well as psychological stress in the post surgical recovery. Pain can be managed by pharmacological methods. Hence post operative pain management heavily relies on pharmacological methods. There are both opioid and non opioid drugs for the management of pain, although opioids are potent analgesics its dependency makes non opioid a better option for pain management. NSAIDS are the most commonly used non opioids, and use of them have advantages of adequate pain control, but has its own disadvantages. Management of post operative pain remains an area for never ending research with newer modalities constantly emerging and outnumbering the obsolete ones. One such upcoming modality is transdermal patch, which provides sustained release of drug through cutaneous route into the bloodstream. Previously done studies have shown that transdermal patch are effective in the management of mild to moderate pain especially in patients with gastric problems and for better compliance, and Diclofenac and ketoprofen are the most commonly used NSAIDs as transdermal patches owing to their potency in pain management. However there exists a lacunae regarding the application of transdermal patches in the field of oral and maxillofacial surgery.
 
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