FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/090745 [Registered on: 11/07/2025] Trial Registered Prospectively
Last Modified On: 11/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparative study between liposomal curcumin versus autologous exosomes after extraction of 3rd molar  
Scientific Title of Study   Comparative evaluation of systemic use of liposomal curcumin versus autologous exosomes in healing of fresh extraction socket- A randomize 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  
Affiliation  Manav rachna international institute of research and science  
Address  Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121004

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  
Affiliation  Professor Department of oral surgery, Manav Rachna international institute of research and science  
Address  Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121004

Faridabad
HARYANA
121004
India 
Phone  9953784571  
Fax    
Email  nitinbhagat.sds@mrei.ac.in  
 
Details of Contact Person
Public Query
 
Name  Jyoti kumari 
Designation  Bds 3rd year  
Affiliation  BDS 3rd year student , Manav Rachna international institute of research and science  
Address  Sri ram nagar, Harpur Lahore P.o-Mit ,police station -ahiyap

Muzaffarpur
BIHAR
842003
India 
Phone  06287528094  
Fax    
Email  drjyotikmri2020@gmail.com  
 
Source of Monetary or Material Support  
Manav rachna dental college Faridabad  
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Private hospital/clinic 
 
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   Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121004
Faridabad
HARYANA 
99537 84571

nitinbhagat.sds@mrei.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee of MRDC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Extraction of 3rd molar 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Exosomes   3rd molar surgery  
Comparator Agent  Liposomal curcumin   Liposomal curcumin after extraction of 3rd molar  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients aged 18 to 50 years
Medically healthy
Indicated for non infected, single tooth extraction
Non smokers or light smokers less than five cigarettes per day
Willing to provide written informed consent and comply with follow up schedule 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Soft tissue healing assessed using Landry, Turnbull & Howley Healing Index at Day 7, Week 4, and Week 8  Duration of study- 3 months  
 
Secondary Outcome  
Outcome  TimePoints 
Postoperative pain using Visual Analog Scale (VAS) Radiographic bone healing assessed via IOPA or CBCT at 4 & 8 weeks   Week4 ,week8  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   22/07/2025 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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   )Title of the Study/Project : compararative evaluation of systemic use of liposomal curcumin versus autologous exosomes in healing of fresh extraction socket - Randomised controlled study .
ii)Aims and methods of the research. To evaluate and compare the effectiveness of systemic liposomal curcumin and autologous exosomes in enhancing soft and hard tissue healing of fresh extraction socket in healthy individuals.
iii)Expected duration of the subject participation : 7 days after the post extraction.
iv)The benefits to be expected from the research to the subject or to others : relief from postoperative healing and inflammation following surgical extraction .
v)Any risk to the subject associated with the study : no
vi)Maintenance of confidentiality of records : yes
vii)Provision of free treatment for research related injury : yes
viii)Compensation of subjects for disability or death resulting from such injury: yes
ix)Freedom of individual to participate and to withdraw from research at any time without penalty or loss of benefits to which the subject would otherwise be Entitled : yes
x)Amount of blood sample in quantity, in Tea Spoon Full, to be taken should be mentioned : around 5 ml of blood.
ix)Freedom of individual to participate and to withdraw from research at any time without penalty or loss of benefits to which the subject would otherwise be Entitled : yes
x)Amount of blood sample in quantity, in Tea Spoon Full, to be taken should be mentioned :
 around 5 ml (for CBC )



 
Close