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CTRI Number  CTRI/2025/07/090255 [Registered on: 07/07/2025] Trial Registered Prospectively
Last Modified On: 05/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparative study to evaluate effectiveness of the titanium platelet rich fibrin and choukrouns platelet rich fibrin in bilaterally lower third molar surgery. 
Scientific Title of Study   Comparative evaluation of the efficacy of the titanium platelet rich fibrin and choukrouns platelet rich fibrin in bilaterally impacted mandibular third molar surgery - A split mouth study 
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. Poorvika S D 
Designation  PG STUDENT 
Affiliation  RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL 
Address  Room no. 3, department of oral and maxillofacial surgery, Rajarajeswari dental college and hospital, no. 14, ramohalli cross, kumbalgodu, mysore road, bangalore 560074

Bangalore Rural
KARNATAKA
560074
India 
Phone  9900535800  
Fax    
Email  poorvikasd@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rohit S 
Designation  Professor 
Affiliation  RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL 
Address  Room no. 3, department of oral and maxillofacial surgery, Rajarajeswari dental college and hospital, no. 14, ramohalli cross, kumbalgodu, mysore road, bangalore 560074

Bangalore Rural
KARNATAKA
560074
India 
Phone  9845439046  
Fax    
Email  rohit.srikanthan@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR Rohit S 
Designation  Professor 
Affiliation  RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL 
Address  Room no. 3, department of oral and maxillofacial surgery, Rajarajeswari dental college and hospital, no. 14, ramohalli cross, kumbalgodu, mysore road, bangalore 560074

Bangalore Rural
KARNATAKA
560074
India 
Phone  9845439046  
Fax    
Email  rohit.srikanthan@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Poorvika S D 
Address  Rajarajeswari dental college and hospital, no. 14, ramohalli cross, kumbalgodu, mysore road, bangalore 560074 
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 
Poorvika S D  Rajarajeswari dental college and hospital  Room no. 3, department of oral and maxillofacial surgery, no. 14, ramohalli cross, kumbalgodu, mysore road, bangalore 560074
Bangalore Rural
KARNATAKA 		 9900535800

poorvikasd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Choukroun platelet rich fibrin  It is a type of prf that is prepared in glass test tubes at 2700 rpm for 12 mins placement of this choukroun platelet rich fibrin in socket of surgically removed impacted mandibular third molar surgery 
Intervention  Titanium platelet rich fibrin  It is a type of prf that is prepared in the titanium tubes. Placement of this titanium platelet rich fibrin in socket of surgically removed impacted mandibular third molar surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients in the age group between 18 TO 60 who fall in ASA 1 and 2 categories 
 
ExclusionCriteria 
Details  PATIENTS WITH LOCALIZED INFECTION IN MANDIBULAR THIRD MOLARS
PATIENTS WITH ANY MAJOR SYSTEMIC ILLNESS WHO FALL INTO ASA 3 AND 4
PATIENTS WITH HISTORY OF ALLERGIES TOWARDS TITANIUM
PATIENTS TAKING MEDICATIONS AFFECTING WOUND HEALING
PATIENTS WITH REDUCED PLATELET COUNT LESS THAN 2 LAKH PER MIL
PREGNANT OR LACTATING WOMEN
SMOKERS
PATIENT WITH PSYCHIATRIC ILLNESS 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess pain, swelling,mouth opening,wound healing, bone formation   first day, third day, seventh day, first month and sixth month. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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 
Date of First Enrollment (India)   21/07/2025 
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="2"
Months="0"
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    

1.   After obtaining approval and clearance from the institutional ethical committee, the patients fulfilling the inclusion criteria will be taken up for the study after obtaining informed consent.

2.   Patients with bilaterally symmetrically impacted mandibular third molar, which requires an extraction for prophylactic reasons will be selected for the study and randomly assigned to one of the two groups.

3.  10 ml of blood will be drawn from the antecubital vein and transferred into sterile medical grade titanium tubes for group 1 and sterile glass tubes for group 2 respectively.

4.  Centrifugation will be carried out at 2800 RPM for 12 minutes for T-PRF and 2700 RPM for 12 min for L-PRF and due to the difference in densities three layers will be formed. The top layer will be pipetted out with a sterile dropper  which consists of acellular plasma .The bottom layer will be the red cell layer, and the middle layer will consist of T-PRF or L-PRF.

     These T- & L-PRF clots are retrieved from titanium and glass tubes using a sterile tweezer and placed on a sterile gauze.

5.     surgical extraction of bilateral impacted mandibular third molars to be done at different intervals. (Minimum of 1 week )

6.     Surgical extraction of impacted molar will be performed after achieving profound anaesthesia with 2% lignocaine hydrochloride with 1:80,000 adrenaline.

7.     The extraction socket will be thoroughly debrided and irrigated with copious saline and betadine irrigation.

8.      After the defect is thoroughly evaluated. In group I cases, the T-PRF will be utilized, and in group II cases, the L-PRF will be utilized to fill the extraction socket followed by primary closure. 

9.     Patients will be recalled on 3rd day, 7th day ,1st month and 6th month.

10.  Following parameters will be assessed:

·       Pain (visual analogue scale)

·       swelling

·       Healing index (Landry et al)

·       Inter incisal measurement.

·       Radiographic evaluation for bone formation will be assessed using IOPAR with grid

 

 
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