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CTRI Number  CTRI/2026/03/106950 [Registered on: 27/03/2026] Trial Registered Prospectively
Last Modified On: 01/09/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two pain-relief medicine combinations for reducing pain and swelling after wisdom tooth removal. 
Scientific Title of Study   Evaluation of the effectiveness of biphasic versus monophasic aceclofenac, paracetamol and serratiopeptidase following mandibular third molar extraction - A randomised controlled trial. 
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 Abhilasha Lad 
Designation  Junior Resident  
Affiliation  Dr DY Patil Dental College and Hospital, Dr DY Patil Vidyapeeth, Pimpri, Pune 411018. 
Address  OPD 9, 3rd floor, Dept. of Oral and Maxillofacial Surgery, Dr. DY Patil Dental College and Hospital, Pimpri, Pune.

Pune
MAHARASHTRA
411018
India 
Phone  9960460918  
Fax    
Email  abhilasha5lad@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sonal Shah 
Designation  Professor  
Affiliation  Dr DY Patil Dental College and Hospital, Dr DY Patil Vidyapeeth, Pimpri, Pune 411018. 
Address  OPD 9, 3rd floor, Dept. of Oral and Maxillofacial Surgery, Dr. DY Patil Dental College and Hospital, Pimpri, Pune.

Pune
MAHARASHTRA
411018
India 
Phone  9833459822  
Fax    
Email  sonal.shah@dpu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Abhilasha Lad 
Designation  Junior Resident  
Affiliation  Dr DY Patil Dental College and Hospital, Dr DY Patil Vidyapeeth, Pimpri, Pune 411018. 
Address  OPD 9, 3rd floor, Dept. of Oral and Maxillofacial Surgery, Dr. DY Patil Dental College and Hospital, Pimpri, Pune.


MAHARASHTRA
411018
India 
Phone  9960460918  
Fax    
Email  abhilasha5lad@gmail.com  
 
Source of Monetary or Material Support  
Dr. DY Patil Dental college and Hospital, Pimpri ,Pune, Maharashtra, India, 411018 
 
Primary Sponsor  
Name  Dr DY Patil Dental College and Hospital 
Address  OPD 9, 3rd floor, Dept. of Oral and Maxillofacial Surgery, Dr. DY Patil Dental College and Hospital, Pimpri, Pune, Maharashtra, India, 411018 
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 Abhilasha Lad  Dr. DY Patil Dental College and Hospital.  OPD 9, 3rd floor, Dept. of Oral and Maxillofacial Surgery, Dr. DY Patil Dental College and Hospital, Pimpri, Pune.
Pune
MAHARASHTRA 		 9960460918

abhilasha5lad@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee. Dr.D.Y.Patil Vidyapeeth, Pune.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M269||Dentofacial anomaly, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bi layered combination of aceclofenac paracetamol and serratiopeptidase   Bi layered combination of aceclofenac (100mg) paracetamol (325mg) and serratiopeptidase (10 mg ) will be given twice a day to 3rd molar extraction patients for 3 days and GI discomfort, pain and swelling will be noted on day 1 , day 2 and day 3 
Comparator Agent  Mono layered combination of aceclofenac paracetamol and serratiopeptidase.  Mono layered combination of aceclofenac (100mg) paracetamol (325mg) and serratiopeptidase (10 mg ) will be given twice a day to 3rd molar extraction patients for 3 days and GI discomfort, pain and swelling will be noted on day 1 , day 2 and day 3 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Indicated for mandibular third molar extraction.
2. Patients willing to provide informed consent and comply with follow-up. 
 
ExclusionCriteria 
Details  1. Known allergy or intolerance to study drug components.
2. Medically compromised patients
3. Pregnant or lactating females.
4. History of chronic NSAID or steroid use. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
GI discomfort on administration of both combinations post operatively.  GI discomfort on administration of both combinations post operatively, on day 1 2 and 3  
 
Secondary Outcome  
Outcome  TimePoints 
Swelling on administration of both combinations post operatively.  On day 1 and 3 
Pain reduction on administration of both combinations post operatively.  On day 1 and 3 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   30/04/2026 
Date of Study Completion (India) 25/05/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 25/05/2026 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

This study is a prospective, randomized, double-blind clinical trial comparing the efficacy of biphasic versus monophasic aceclofenac, paracetamol, and serratiopeptidase in managing postoperative pain, swelling, and gastrointestinal discomfort following mandibular third molar extraction.

Thirty patients will be randomly allocated into two groups receiving either the biphasic or monophasic formulation. Pain (VAS), swelling (tape measurements), and gastrointestinal discomfort (Bothersomeness Scale) will be assessed on postoperative Day 1 and Day 3. The primary objective is to compare the clinical effectiveness of both formulations, with secondary outcomes including gastrointestinal discomfort, rescue analgesic requirement, and patient compliance. Data will be analyzed using unpaired t-test and Mann–Whitney U test.

 
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