| CTRI Number |
CTRI/2025/01/079783 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
study on advanced platelet rich fibrin for treating mandibular fractures. |
|
Scientific Title of Study
|
Evaluation of efficacy of advanced platelet rich fibrin in healing of mandibular fractures- A prospective clinical study |
| Trial Acronym |
HEAL-PRF |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yash Vyas |
| Designation |
post graduate student |
| Affiliation |
Sri Siddhartha Dental College |
| Address |
Room no.2, department of oral and maxillofacial surgery, Sri Siddhartha Dental College,
Agalakote, B.H. Road,
Tumkur - 572 107,
Karnataka - India
Tumkur
KARNATAKA
572107
India |
| Phone |
9409043330 |
| Fax |
|
| Email |
vyasy0024@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Kumar R |
| Designation |
Head of the department |
| Affiliation |
Sri Siddhartha Dental College |
| Address |
Room no.2, department of oral and maxillofacial surgery, Sri Siddhartha Dental College,
Agalakote, B.H. Road,
Tumkur - 572 107,
Karnataka - India
Tumkur
KARNATAKA
572107
India |
| Phone |
9845417365 |
| Fax |
|
| Email |
mahu017@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh Kumar R |
| Designation |
Head of the department |
| Affiliation |
Sri Siddhartha Dental College |
| Address |
Room no.2, department of oral and maxillofacial surgery, Sri Siddhartha Dental College,
Agalakote, B.H. Road,
Tumkur - 572 107,
Karnataka - India
Tumkur
KARNATAKA
572107
India |
| Phone |
9845417365 |
| Fax |
|
| Email |
mahu017@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Siddhartha Dental College,
Agalakote, B.H. Road,
Tumkur - 572 107,
Karnataka - India |
|
|
Primary Sponsor
|
| Name |
Dr Yash Vipulkumar Vyas |
| Address |
Room no.2, department of oral and maxillofacial surgery, Sri Siddhartha Dental College,
Agalakote, B.H. Road,
Tumkur - 572 107,
Karnataka - India |
| Type of Sponsor |
Other [self sponsor] |
|
|
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 Yash vyas |
Sri Siddhartha Dental College and hospital |
Room no.2, department of oral and maxillofacial surgery, Sri Siddhartha Dental College,
Agalakote, B.H. Road,
Tumkur - 572 107,
Karnataka - India
Tumkur
KARNATAKA |
9409043330
vyasy0024@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sri siddhartha dental college and hospital institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S026||Fracture of mandible, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
advanced platelet rich fibrin |
Only once just after the reduction of fracture segment. prepared from 10ml patient blood |
| Comparator Agent |
fracture healing without advanced platelet rich fibrin |
not applying Advanced platelet rich fibrin. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients requiring open reduction with internal fixation of bilateral mandibular fracture under general anesthesia.
Patients who are willing and be able to provide informed consent and be available for multiple follow up visits.
Patients with the age group ranging from 18-60 years.
|
|
| ExclusionCriteria |
| Details |
Patients with any preexisting pathology.
Patients with uncontrolled systemic illness.
Patients who is taking Bisphosphonates drug.
Interfragmentary distance between fractures more than 1 mm.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| healing will be faster for mandibular fractures where we have applied Advanced-platelet rich fibrin |
post-operatively day 1 and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| advanced platelet rich fibrin will be reduce swelling on applied site |
post-operatively day-1 & day-7 |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| 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 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
|
•A-PRF is a second generation PRF that has been reported to aid in faster wound healing and bone healing due to the enhanced presence of platelets and neutrophilic granulocytes. These cells influence the differentiation of host macrophages after its implantation at the site, which in turn aid with bone and soft tissue regeneration. The release of growth factors like TGF-b1, PDGF, EGF, and IGF have been reported to be greater thereby accelerating the process of bone healing. A-PRF concentrates have shown to cause higher proliferation and migration of hematopoietic growth factors too thereby producing better angiogenesis at the site.
•In this study, the effect of A-PRF on mandibular fracture healing will be evaluated post reduction and fixation of fracture segments. |