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CTRI Number  CTRI/2025/12/099872 [Registered on: 29/12/2025] Trial Registered Prospectively
Last Modified On: 22/08/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two platelet-based treatments on pain, swelling,mouth opening and healing after lower wisdom tooth removal. 
Scientific Title of Study   A comparison of the efficacy of advanced platelet-rich fibrin and leukocyte platelet-rich fibrin on postoperative pain, swelling, trismus, and soft tissue wound healing after removal of impacted mandibular third molar: A 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  Dr. Jyotsna 
Designation  PhD Scholar 
Affiliation  Geetanjali Dental and Research institute 
Address  Dapartment Of Oral and Maxillofacial Surgery,Geetanjali Dental and Research institute, Manva Kheda ,Udaipur ,Rajasthan
Dapartment Of Oral and Maxillofacial Surgery,Geetanjali Dental and Research institute, Manva Kheda ,Udaipur ,Rajasthan
Udaipur
RAJASTHAN
313001
India 
Phone  7906579610  
Fax    
Email  01.jyotsna@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Shallu Bansal 
Designation  PhD Guide (Professor and Head) 
Affiliation  Geetanjali Dental and Research Institute 
Address  Department of oral and maxillofacial surgery,Geetanjali Dental and Research Institute,Manva Kheda, Udaipur,Rajasthan
Geetanjali Dental and Research Institute,Manva Kheda, Udaipur,Rajasthan
Udaipur
RAJASTHAN
313001
India 
Phone  9116155666  
Fax    
Email  drshallu23@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Jyotsna 
Designation  PhD Scholar 
Affiliation  Geetanjali Dental and Research Institute 
Address  Department of oral and maxillofacial surgery,Geetanjali Dental and Research Institute,Manva Kheda, Udaipur,Rajasthan
Department of oral and maxillofacial surgery,Geetanjali Dental and Research Institute,Manva Kheda, Udaipur,Rajasthan
Udaipur
RAJASTHAN
3130001
India 
Phone  7906579610  
Fax    
Email  01.jyotsna@gmail.com  
 
Source of Monetary or Material Support  
Uttaranchal dental and medical research institute 
 
Primary Sponsor  
Name  Dr Jyotsna 
Address  Geetanjali Dental and Research Institute,Manva Kheda,Udaipur,Rajasthan 
Type of Sponsor  Other [self] 
 
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 Jyotsna  uttaranchal dental and medical research institute  Department of oral and maxillofacial surgery
Dehradun
UTTARANCHAL 		 7906579610

01.jyotsna@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee,Uttaranchal dental and medical research institute,Dehradun  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K011||Impacted teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Advanced Platelet-Rich Fibrin  Advanced platelet-rich fibrin is a second-generation autologous platelet concentrate prepared using lower centrifugal forces (approximately 1500 rpm for 14 minutes). The fibrin clot obtained is rich in platelets and leukocytes and is placed in the extraction socket following impacted mandibular third molar removal to aid postoperative healing by enhancing growth factor release and angiogenesis. 
Intervention  leukocyte platelet-rich fibrin   Leukocyte platelet-rich fibrin is a second-generation autologous platelet concentrate containing platelets and leukocytes within a dense fibrin matrix. It is prepared by collecting venous blood in sterile tubes without anticoagulant and centrifuging immediately at approximately 3000 rpm for 10 minutes. The prepared fibrin clot is placed in the extraction socket after impacted mandibular third molar removal to promote soft tissue healing and reduce postoperative complications. 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Patients between age of 18-45 years of both genders.
2. Patients indicated for surgical removal of moderately difficult impacted mandibular third molar as per Modified Pederson’s Index.
3. Healthy patients falling under ASA I and ASA II
4. Subjects able and willing to provide written informed consent and compliant with study procedure.
 
 
ExclusionCriteria 
Details  1. Patients with mouth opening less than 30mm.
2. Patient with allergy with NSAIDS.
3. Patients having history of drug abuse.
4. Patients having any systemic or local immunodeficiency.
5. Patient is under regular analgesics and anti-depressants.
6. Having any blood coagulation impairment.
7. Presence of any acute oral infection.
8. Have been suffering with uncontrolled diabetes or other systemic diseases.
9. Having previous history of radiation therapy in the head and neck region.
10. Pregnant and nursing women.
11. Patient with the history of smoking and alcohol.
12. Soft tissue impactions.
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Post operative pain intensity following impacted mandibular third molar removal measured by visual analogue scale.  post operative 1st,3rd,7th and 15th day. 
 
Secondary Outcome  
Outcome  TimePoints 
Post operative trismus measured by interincisal distance by vernier calliper.  Post operative 1st,3rd,7th and 15th day. 
Post operative swelling measured by Laskin method.  post operative 1st,3rd,7th and 15th day. 
Post operative soft tissue wound healing measured by criteri given by Landry et al.  post operative 1st,3rd,7th and 15th day. 
 
Target Sample Size   Total Sample Size="144"
Sample Size from India="144" 
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 
Date of First Enrollment (India)   21/01/2026 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Impacted mandibular third molar removal is commonly associated with post-operative pain, swelling, trismus, and delayed soft-tissue wound healing. Autologous platelet-rich fibrin (PRF) has been shown to enhance healing and reduce post-operative morbidity. This study is designed to compare the efficacy of advanced platelet-rich fibrin (APRF) and leukocyte-platelet rich fibrin (LPRF) in reducing post-operative pain, swelling, trismus, and improving soft-tissue wound healing following surgical removal of impacted mandibular third molars. This is a randomized, parallel-group, interventional clinical trial in which eligible participants will be randomly allocated to receive either APRF or LPRF at the extraction site. Post-operative pain will be assessed as the primary outcome, while swelling, trismus, and soft-tissue wound healing will be evaluated as secondary outcomes at predefined post-operative time points. 
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