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CTRI Number  CTRI/2025/06/088385 [Registered on: 06/06/2025] Trial Registered Prospectively
Last Modified On: 05/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Gelfoam with diclofenac placed after removing teeth compared with tablet diclofenac for relief of pain 
Scientific Title of Study   Comparison Of Efficacy Of Gelfoam Soaked In Diclofenac Placed Inside Extraction Socket With Oral Diclofenac In Postoperative Analgesia.”– A RANDOMISED SPLIT MOUTH STUDY 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vini D Machchhar 
Designation  MDS student 
Affiliation  Yenepoya dental college 
Address  Department of oral and maxillofacial surgery Yenepoya dental college Deralakatte Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9426391941  
Fax    
Email  vinimachchhar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jagdish Chandra 
Designation  Head of the Department 
Affiliation  Yenepoya Dental College 
Address  Department of oral and maxillofacial surgery Yenepoya Dental College Deralakatte Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9845150871  
Fax    
Email  jagadishmds@redfmail.com  
 
Details of Contact Person
Public Query  
Name  Vini D Machchhar 
Designation  Mds student 
Affiliation  Yenepoya dental college 
Address  Department of oral and maxillofacial surgery Yenepoya dental college Deralakatte Mangalore


KARNATAKA
575018
India 
Phone  9426391941  
Fax    
Email  vinimachchhar@gmail.com  
 
Source of Monetary or Material Support  
Department of oral and maxillofacial surgery Yenepoya dental college mangalore Karnataka 570518  
 
Primary Sponsor  
Name  Dr Vini D Machchhar  
Address  Department of oral and maxillofacial surgery Yenepoya dental college Deralakatte Mangalore  
Type of Sponsor  Private medical college 
 
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 Vini D Machchhar  Yenepoya Dental College  Department of oral and maxillofacial surgery 1st floor Room no 4 Yenepoya dental college Deralakatte Mangalore 570518
Dakshina Kannada
KARNATAKA 		 9426391941

vinimachchhar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Yenepoya ethics committe 1  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Carious tooth or any reason indicating extraction of tooth 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Local route for diclofenac post extraction  Diclofenac soaked gelfoam placed inside the extraction socket 50 mg diclofenac Placed for 7 days 
Comparator Agent  Oral route of diclofenac compared with local route   gelfoam soaked with diclofenac placed inside the extraction socket with oral diclofenac 50mg diclofenac Prescribed for 5 days post extraction 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients with BILATERAL SYMMETRICAL MAXILLARY OR MANDIBULAR teeth indicated for extraction.

2.Patients undergoing intra-alveolar extraction within 10 minutes duration.
 
 
ExclusionCriteria 
Details  1. Patients with known allergy to NSAIDS.

2. Pregnant women.

3. Patients on any other analgesics or corticosteroids.

4. Patients with history of systemic diseases like bronchial asthma, epilepsy, and emotional and psychosomatic disorders.

5. Patients unwilling to consent for the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The benefit is it helps determine the optimal route for diclofenac delivery based on factors like bioavailability and patient tolerance.
 		 Pain will be assessed for 7 days regularly and will be recorded
Healing will be recorded at 7 days post extraction  
 
Secondary Outcome  
Outcome  TimePoints 
The need for the current study is to examine and assess efficacy of diclofenac gel foam placed in extraction sockets as an alternative to oral analgesic.

 		 6 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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/ Phase 4 
Date of First Enrollment (India)   18/06/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
  1. The need for the current study is to examine and assess efficacy of diclofenac gel foam  placed  in extraction sockets as an alternative to oral analgesic. This study will provide with new route of drug administration and avoid problems people face with taking oral medicines like gastritis, ulcerations. Here we will do the trial in 20 patients in which one side when tooth is extracted oral diclofenac will be given and after 7 days when other side extraction is done gelfoam soaked in diclofenac will be given and assessed for pain and healing.
 
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