| CTRI Number |
CTRI/2025/09/095482 [Registered on: 30/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Faster recovery after wisdom tooth surgery: Platelet treatment with or without steroid |
|
Scientific Title of Study
|
Invivo comparison between Patelet Rich Fibrin and Platelet Rich Fibrin with Corticosteroid following Mandibular third molar extraction |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Initha K |
| Designation |
Resident Intern |
| Affiliation |
Tagore Dental College and Hospital |
| Address |
Tagore Dental College and Hospital Rathinamangalam Melakottaiyur post Chennai
TAMIL NADU
600127
India |
| Phone |
7299757300 |
| Fax |
|
| Email |
inikk2021@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jedidiah Fredrick Abisheg Britto |
| Designation |
Senior Lecturer |
| Affiliation |
Tagore Dental College and Hospital |
| Address |
Tagore Dental College and Hospital Rathinamangalam Melakottaiyur post Chennai
Kancheepuram
TAMIL NADU
600127
India |
| Phone |
9003109484 |
| Fax |
|
| Email |
drjedidiah.abisheg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jedidiah Fredrick Abisheg Britto |
| Designation |
Senior Lecturer |
| Affiliation |
Tagore Dental College and Hospital |
| Address |
Tagore Dental College and Hospital Rathinamangalam Melakottaiyur post Chennai
Kancheepuram
TAMIL NADU
600127
India |
| Phone |
9003109484 |
| Fax |
|
| Email |
drjedidiah.abisheg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tagore Dental College and Hospital Rathinamangalam Melakottaiyur post Chennai India 600127 |
|
|
Primary Sponsor
|
| Name |
Initha K |
| Address |
Tagore Dental College and Hospital Rathinamangalam Melakottaiyur post Chennai 600127 |
| 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 Jedidiah Fredrick Abisheg Britto |
Tagore Dental College and Hospital |
Room no 3
Department of oral and maxillofacial surgery
Kancheepuram
TAMIL NADU |
9003109484
drjedidiah.abisheg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Platelet Rich Fibrin(PRF) |
Autologous PRF combined with corticosteroid and placed into the extraction socket following third molar removal |
| Intervention |
Platelet Rich Fibrin(PRF) |
Autologous PRF prepared from patients venous blood and placed into the extraction socket following third molar removal |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients should be greater than 18 years of age.
2.Patient with impacted third molar(vertical,mesioangular,distoangular,horizontal) requiring extraction or surgical removal.
|
|
| ExclusionCriteria |
| Details |
1.Patients having periapical pathologies or local tooth related pathologies.
2.Patients having any systemic diseases.
3.Patients with habits like smoking and alcohol consumption.
4.Patients who are not willing to participate in this study and will not provide informed consent.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The reduction of pain, swelling and soft tissue healing will be seen in the PRF with corticosteroid group.
|
1ST DAY,3RD DAY,7TH DAY POSTOPERATIVELY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The reduction of pain, swelling and soft tissue healing will be seen in the PRF with corticosteroid group.
|
1ST DAY,3RD DAY,7TH DAY POSTOPERATIVELY |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/10/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This interventional, prospective, randomized controlled trial is designed to evaluate and compare the clinical effectiveness of Platelet Rich Fibrin (PRF) and Platelet Rich Fibrin combined with corticosteroid in patients undergoing surgical extraction of impacted mandibular third molars.
A total of 50 patients meeting the inclusion and exclusion criteria will be recruited from the Department of Oral and Maxillofacial Surgery, Tagore Dental College and Hospital. Participants will be randomly assigned into two groups:
Group A: Extraction socket filled with PRF alone
Group B: Extraction socket filled with PRF mixed with corticosteroid gel
Postoperative outcomes including pain, swelling, and wound healing will be assessed on the 1st, 3rd, and 7th postoperative days. Pain will be measured using the Visual Analogue Scale (VAS), while swelling will be evaluated using three-line facial measurements.
The study aims to determine whether the addition of corticosteroid to PRF provides superior pain relief, better wound healing, and reduced postoperative swelling compared to PRF alone. |