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CTRI Number  CTRI/2025/05/086285 [Registered on: 05/05/2025] Trial Registered Prospectively
Last Modified On: 01/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological
Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   The ability of two different blood constituents to heal sockets after removal of infected, dead, and treated teeth. 
Scientific Title of Study   The efficacy of L-PRF and L-PRP in post extraction sockets of endodontically treated and devitalized teeth- a randomized control 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  Dr Vrinda Rajagopal 
Designation  MDS trainee 
Affiliation  Dr DY Patil dental college and hospital, Pimpri, Pune 
Address  Department of oral and maxillofacial surgery, Room No. 9, 3rd floor, Dr DY Patil dental college and hospital, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  9633392138  
Fax    
Email  23040111.dental@dpu.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr BM Rudagi 
Designation  PROFESSOR AND HOD 
Affiliation  Dr DY Patil dental college and hospital, Pimpri, Pune 
Address  Department of oral and maxillofacial surgery, Room No. 9, 3rd floor, Dr DY Patil dental college and hospital, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  9673494111  
Fax    
Email  drbmr17@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr BM Rudagi 
Designation  PROFESSOR AND HOD 
Affiliation  Dr DY Patil dental college and hospital, Pimpri, Pune 
Address  Department of oral and maxillofacial surgery, Room No. 9, 3rd floor, Dr DY Patil dental college and hospital, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  9673494111  
Fax    
Email  drbmr17@gmail.com  
 
Source of Monetary or Material Support  
no sponsor for the study. Department of oral and maxillofacial surgery, Room No. 9, 3rd floor, Dr DY Patil dental college and hospital, Pimpri, Pune, Maharashtra, India- 411018 
 
Primary Sponsor  
Name  Dr DY Patil dental college and hospital Pimpri Pune 
Address  Department of oral and maxillofacial surgery, Room No. 9, 3rd floor, Dr DY Patil dental college and hospital, Pimpri, Pune, Maharashtra, India- 411018 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vrinda Rajagopal  Dr DY Patil dental college and hospital, Pimpri, Pune  Department of oral and maxillofacial surgery, Room No. 9, 3rd floor, Dr DY Patil dental college and hospital, Pimpri, Pune, Maharashtra, India- 411018
Pune
MAHARASHTRA 		 9633392138

vrindarajagopal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS SUB COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z006||Encounter for examination for normal comparison and control in clinical research program,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  L-PRF  PRF clot is placed in the socket and covered with AbGel. The socket is then sutured with 3-0 silk suture. Post-operative CBCT will be taken immediately after extraction. Post-operative medications will be prescribed. Patient will be recalled after 8 weeks for follow up and CBCT  
Comparator Agent  L-PRP  PRP clot is placed in the socket and covered with AbGel.The socket is then sutured with 3-0 silk suture.Post-operative CBCT will be taken immediately after extraction.Post-operative medications will be prescribed.Patient will be recalled after 8 weeks for follow up and CBCT.  
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  45.00 Day(s)
Gender  Both 
Details  1.Teeth that are Root canal treated and indicated for extraction
2. Root pieces that are indicated for extraction
3. Patients who are willing for blood sample collection for processing L-PRF and L-PRP
 
 
ExclusionCriteria 
Details  1. Ankylosed teeth
2. Teeth with periapical pathology or lesions
3. Any pre-malignant or malignant lesions
4. Patients with any blood dyscrasias
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Post-operative pain will be assessed in groups A and B using the Visual Analog Scale.
Post-operative wound healing groups A and B will be assessed using Landry’s and modified Landry’s wound healing index.
Post-operative bone regeneration levels will be assessed in groups A and B by CBCT.
 		 0 8weeks 
 
Secondary Outcome  
Outcome  TimePoints 
pain  0 5days 
 
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 3/ Phase 4 
Date of First Enrollment (India)   15/05/2025 
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  

Aim of the study:

To assess the efficacy of L-PRF and L-PRP in post extraction sockets of endodontically treated and devitalized teeth

Objective of the study:

  1. To assess pain using Visual Analog Scale (VAS)

2.    To assess bone levels using CBCT

3.      To assess wound healing using Inflammatory, Proliferative and Remodelling Scale (IPR)

  

Describe how the study will be done in a step-wise chronological sequence:

           Surgical procedures

Patients reporting to the department of Oral and Maxillofacial surgery OPD and who fit the into the inclusion criteria will be selected for the study. Detailed case history with informed written consent will be obtained from patients. Patients will be divided into Group A and Group B using lottery method. Nerve block will be given according to the tooth to be extracted and forceps are chosen. Once the tooth is extracted, curettage of the socket is done with thorough saline irrigation.

GROUP A

 PRP clot is placed in the socket and covered with AbGel.The socket is then sutured with 3-0 silk suture. Post-operative CBCT will be taken immediately after extraction.Post-operative medications will be prescribed.  Patient will be recalled after 8 weeks for follow up and CBCT.

GROUP-B

PRF clot is placed in the socket and covered with AbGel.The socket is then sutured with 3-0 silk suture.Post-operative CBCT will be taken immediately after extraction. Post-operative medications will be prescribed. Patient will be recalled after 8 weeks for follow up and CBCT.


 
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