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CTRI Number  CTRI/2024/08/072195 [Registered on: 09/08/2024] Trial Registered Prospectively
Last Modified On: 08/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Preventive
Dentistry
Nutraceutical 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative analysis of Dietary Supplement vs Analgesic in managing pain after wisdom tooth removal  
Scientific Title of Study   Comparative evaluation of Palmitoylethanolamide (PEA) vs Ketorolac in Pain management after Third Molar Surgery A Randomised Controlled 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  Dr. Nitin Bhagat 
Designation  Professor, Department of Oral and Maxilllofacial surgery, Manav Rachna Dental College 
Affiliation  Manav Rachna Dental College  
Address  Q block, Department of Oral and Maxillofacial Surgery, Room no. 2, Sector-43, Surajkund-Badkhal road, Faridabad, Haryana

Faridabad
HARYANA
121004
India 
Phone  9953784571  
Fax    
Email  nitinbhagat.sds@mrei.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr. Nitin Bhagat 
Designation  Professor, Department of Oral and Maxilllofacial surgery, Manav Rachna Dental College 
Affiliation  Manav Rachna Dental College  
Address  Q Block, Department of Oral and Maxillofacial Surgery, Room no.2 Sector-43, Surajkund-Badkhal road, Faridabad, Haryana

Faridabad
HARYANA
121004
India 
Phone  9953784571  
Fax    
Email  nitinbhagat.sds@mrei.ac.in  
 
Details of Contact Person
Public Query  
Name  Hemang Kapoor  
Designation  Dental Intern  
Affiliation  Manav Rachna Dental College  
Address  Q Block, Department of Oral and Maxillofacial Surgery, Room no.2 Sector-43, Surajkund-Badkhal road, Faridabad, Haryana

Faridabad
HARYANA
121004
India 
Phone  8130655482  
Fax    
Email  hemangkapoor2012@gmail.com  
 
Source of Monetary or Material Support  
Dr. Hemang Kapoor Location of the study : Manav Rachna Dental College, Sector 43, Surajkund-Badkhal Road, Faridabad, Haryana, India Pincode - 121004 
 
Primary Sponsor  
Name  Hemang Kapoor  
Address  Sector 43, Surajkund-Badhkal Road, Faridabad, Haryana 121004 
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 Nitin Bhagat   Manav Rachna Dental College   Q block, Department of Oral and Maxillofacial Surgery, Room number 2, Sector 43 SurajKund Badhkal Road Faridabad Haryana 121004
Faridabad
HARYANA 		 9953784571

nitinbhagat.sds@mrei.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee, Manav Rachna Dental College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K011||Impacted teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ketorolac   Ketorolac 10mg QID x 5 days  
Intervention  Palmitoylethanolamide   Palmitoylethanolamide 300mg BD x 5 days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Patients aged between 18 to 40 under going 3rd molar extraction.
No systemic disease. Healthy human volunteer. Does not smoke or consume any substance that interferes with study.  
 
ExclusionCriteria 
Details  Patients with known allergies to Palmitoylethanolamide or Ketorolac.
History of gastrointestinal ulcers, renal or hepatic impairment.
Pregnant woman and lactating mother.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain intensity as measured by VAS scores at 24 and 48 hours post-surgery.
 		 Pain intensity as measured by VAS scores at 24 and 48 hours post-surgery.
 
 
Secondary Outcome  
Outcome  TimePoints 
Total consumption of rescue medication.
Patient satisfaction scores.
Incidence of adverse events
Functional outcomes such as the ability to return to normal activities
 		 Patient satisfaction scores to be checked at 7th & 14th day.

 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 4 
Date of First Enrollment (India)   01/09/2024 
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="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   Comparative evaluation of Palmitoylethanolamide vs Ketorolac in pain management after 3rd molar surgery. 
Non steroidal anti inflammatory drugs come with significant side effects. Palmitoylethanolamide an endogenous fatty acid has shown promise in managing pain with minimal side effects. 
This study aims to compare the efficacy and safety of Palmitoylethanolamide against Ketorolac in this context. 
This is a randomised, double blinded, control study. 
Duration of study will be 6 months. 80 patients will be selected with a control group that will be given Ketorolac and a study group that will be given Palmitoylethanolamide. 
Inclusion criteria will include patients aged between 18 to 40 with no systemic diseases or history smoking or consuming any other substances that will interfere with study. Exclusion criteria will be patients with known allergies to Ketorolac or Palmitoylethanolamide, history of gastric ulcers, renal or hepatic impairment, pregnant woman and lactating mother.
Pain will be assessed using VAS scale at multiple points post op. 
The study aims to determine if Palmitoylethanolamide is as effective as Ketorolac with minimal side effects. 

 
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