| 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
|
|
|
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
|
|
|
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 |
|
|
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 )
|