| CTRI Number |
CTRI/2026/01/100521 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
How Effective Is A-PRF in Reducing Pain and Swelling After Lower Wisdom Tooth Surgery |
|
Scientific Title of Study
|
Effectiveness of Advanced Platelet-Rich Fibrin on Postoperative Sequelae For Impacted Mandibular Third Molar Surgery: A Split Mouth Randomized Controlled Trial. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MEENAKSHI SINGH |
| Designation |
Post Graduate Student |
| Affiliation |
Subharti Dental College and Hospital |
| Address |
Department of Oral and Maxillofacial Surgery
Meerut
UTTAR PRADESH
250002
India |
| Phone |
8368137061 |
| Fax |
|
| Email |
meenakshisingh.021094@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Apoorva Mowar |
| Designation |
Professor |
| Affiliation |
Subharti Dental College and Hospital |
| Address |
Department Of Oral and Maxillofacial Surgery
Meerut
UTTAR PRADESH
250002
India |
| Phone |
9719051006 |
| Fax |
|
| Email |
drmowarapoorva@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MEENAKSHI SINGH |
| Designation |
Post Graduate Student |
| Affiliation |
Subharti Dental College and Hospital |
| Address |
Department of Oral and Maxillofacial Surgery
Meerut
UTTAR PRADESH
250002
India |
| Phone |
8368137061 |
| Fax |
|
| Email |
meenakshisingh.021094@gmail.com |
|
|
Source of Monetary or Material Support
|
| Subharti Dental College and Hospital
Subhartipuram Uttar Pradesh India
250002 |
|
|
Primary Sponsor
|
| Name |
Meenakshi Singh |
| Address |
Department of Oral and Maxillofacial Surgery
Subharti Dental College And Hospital
Subhartipuram, Uttar Pradesh, India
250002 |
| 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 |
| Meenakshi Singh |
Subharti Dental College and Hospital |
Department of oral and maxillofacial surgery
Meerut
UTTAR PRADESH |
8368137061
meenakshisingh.021094@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blood Derivative |
Advanced Platelet Rich Fibrin |
| Comparator Agent |
Conventional Treatment |
Extraction Socket is treated conventionally without Advanced Platelet Rich Fibrin |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Healthy patient aged 18-45 years of any sex.
Need for extraction of bilateral mandibular 3rd molar
Minimal to moderate difficulty as Pederson difficulty index
Same level of difficulty in bilateral impacted mandibular third molar tooth
Patient willing to be part of the study |
|
| ExclusionCriteria |
| Details |
Medically compromised patient unfit for surgery
Patients with history of smoking or regular alcohol consumption
Pregnant patient or lactating mother
Patient with drug allergies to post extraction prescribed medications |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain
Analgesic consumption
Postoperative swelling
Trismus
Bone healing
|
Pain at 1st, 2nd, 3rd and 7th day
Analgesic consumption at 1st, 2nd, 3rd and 7th day
Postoperative swelling at 3rd and 7th day
Trismus at 3rd and 7th day
Bone healing at 4 weeks |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
27/01/2026 |
| 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="2"
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
|
A minimum of 20 healthy patients requiring bilateral impacted mandibular third molar extraction were selected and randomized into two equal groups. All patients underwent transalveolar extraction under aseptic conditions. In the test group, advanced platelet-rich fibrin (A-PRF) was placed in the extraction socket, while in the control group the socket was sutured without A-PRF. Both groups received postoperative antibiotics and analgesics for five days. Outcomes assessed included pain (VAS), analgesic consumption, swelling (linear measurements), mouth opening (interincisal distance), and bone healing by comparing pre- and postoperative findings. |