| CTRI Number |
CTRI/2025/12/098765 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
01/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to see whether adding Platelet-Rich Plasma (PRP) helps patients heal faster after wisdom tooth removal. |
|
Scientific Title of Study
|
Comparative and Interventional Study on
Healing Outcomes with and Without Platelet
Rich Plasma (PRP) in Third Molar Surgery |
| 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 Lahar Patni |
| Designation |
Postgraduate Student |
| Affiliation |
KM Shah Dental College |
| Address |
Department of Oral and Maxillofacial Surgery , room number 2 , KM Shah Dental College and Hospital , Vadodara
Department of Oral and Maxillofacial Surgery , room number 2 , KM Shah Dental College and Hospital , Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
7028715890 |
| Fax |
|
| Email |
laharpatni1103@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Shah |
| Designation |
PG Guide |
| Affiliation |
KM Shah Dental College |
| Address |
Department of Oral and Maxillofacial Surgery , room number 2 , KM Shah Dental College and Hospital , Vadodara
Department of Oral and Maxillofacial Surgery , room number 2 , KM Shah Dental College and Hospital , Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
7028715890 |
| Fax |
|
| Email |
dr.shahrakesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lahar Patni |
| Designation |
Postgraduate Student |
| Affiliation |
KM Shah Dental College |
| Address |
Department of Oral and Maxillofacial Surgery , room number 2 , KM Shah Dental College and Hospital , Vadodara
Department of Oral and Maxillofacial Surgery , room number 2 , KM Shah Dental College and Hospital , Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
7028715890 |
| Fax |
|
| Email |
laharpatni1103@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Lahar Patni |
| Address |
KM Shah Dental College and Hospital Sumandeep Vidyapeeth Deemed to be university Address At & Post Piparia Taluka Waghodia District Vadodara Gujarat State (India)
Pincode - 391760 |
| Type of Sponsor |
Other [Self] |
|
|
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 Lahar Patni |
KM Shah Dental College and Hospital , Sumandeep Vidyapeeth Deemed to be university. vadodara |
Ground floor , Department of Oral and Maxillofacial Surgery number 2 , Vadodara , Gujarat
Vadodara
GUJARAT |
7028715890
laharpatni1103@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 3||Administration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Healing outcome With Platelet Rich Plasma in third molar Surgery |
It involves placement of PRP gel into the healing socket of third molar which will result in reduced swelling and pain |
| Comparator Agent |
Healing Outcome Without Platelet Rich Plasma in third molar Surgery |
Healing outcome without prp in the control group generally shows normal physiological repair but with slower healing and less regenerative potential compare to PRP treated site |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing removal of mandibular molar , patients with age 18 to 50 years , systematically healthy patients, patients willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Participants who are not ready to participate in the study , Patients with Oral Submucous Fibrosis , Patients with severe medical illness , Active infection present at the extraction site , Participants with age less than 18 years , patients with pathologies involving third molar |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will help us determine the effectiveness of PRP in healing outcome of third molar surgery to reduced swelling and pain |
Before , 3rd day and 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinician can use this technique to overcome the problem of pain and swelling in healing outcome of third molar surgery |
Before , 3rd day and 7th day |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
22/12/2025 |
| 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="1"
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
|
The overall aim is to evaluate the therapeutic effect of Platelet-Rich Plasma (PRP) in third molar extraction sockets, focusing on reducing pain, improving wound healing, and enhancing patient comfort during the post-operative period. Surgical removal of impacted third molars frequently results in post-surgical issues such as pain, swelling, and trismus (limited mouth opening). PRP is an autologous concentrate of platelets suspended in plasma, rich in growth factors (like Platelet derived growth factor, Transforming growth factor-b, and Vascular endothelial growth factor). These factors promote angiogenesis, tissue regeneration, soft tissue repair, and accelerate recovery. The study objectives include comparing post-operative pain (using the Visual Analogue Scale), wound healing (using the Healing Index), mouth opening, and swelling between groups with and without PRP on the 3rd and 7th post-operative days. The required sample size is 70 participants (35 per group). The ultimate expected outcome is that PRP will prove effective in decreasing post-operative pain and enhancing healing at a faster rate following mandibular third molar extraction. |