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CTRI Number  CTRI/2025/07/091427 [Registered on: 22/07/2025] Trial Registered Prospectively
Last Modified On: 14/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   COMPARATIVE EVALUATION OF PLATELET RICH CONCENTRATES(L-PRF AND A-PRF) IN EXTRACTED TOOTH SOCKETS AND THEIR EFFECT ON ORTHODONTIC TOOTH MOVEMENT -A RANDOMIZED CONTROLLED STUDY 
Scientific Title of Study   A COMPARATIVE EVALUATION OF THE EFFECT OF ADVANCED PLATELET RICH FIBRIN AND LEUKOCYTE - PLATELET RICH FIBRIN ON ORTHODONTIC TOOTH MOVEMENT: A RANDOMIZED CONTROLLED 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 ANSH THAKKAR 
Designation  MDS RESIDENT  
Affiliation  MANUBHAI PATEL DENTAL COLLEGE AND HOSPITAL 
Address  DEPT OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS, MANUBHAI PATEL DENTAL COLLEGE AND HOSPITAL, VISHWAJYOTI ASHRAM, NEAR VIDHYAKUNJ SCHOOL, MUJMAHUDA ,VADODARA , GUJARAT 390011

Vadodara
GUJARAT
390011
India 
Phone  7567086543  
Fax    
Email  anshvthakar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR PADMAJA ARORA  
Designation  PROFESSOR 
Affiliation  MANUBHAI PATEL DENTAL COLLEGE AND HOSPITAL 
Address  DEPT OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS, MANUBHAI PATEL DENTAL COLLEGE AND HOSPITAL, VISHWAJYOTI ASHRAM, NEAR VIDHYAKUNJ SCHOOL, MUJMAHUDA ,VADODARA , GUJARAT 390011

Vadodara
GUJARAT
390011
India 
Phone  9033975429  
Fax    
Email  padmaja2216@yahoo.co.in   
 
Details of Contact Person
Public Query
 
Name  DR ANSH THAKKAR 
Designation  MDS RESIDENT  
Affiliation  MANUBHAI PATEL DENTAL COLLEGE AND HOSPITAL 
Address  DEPT OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS, MANUBHAI PATEL DENTAL COLLEGE AND HOSPITAL, VISHWAJYOTI ASHRAM, NEAR VIDHYAKUNJ SCHOOL, MUJMAHUDA ,VADODARA , GUJARAT 390011

Vadodara
GUJARAT
390011
India 
Phone  7567086543  
Fax    
Email  anshvthakar@gmail.com  
 
Source of Monetary or Material Support  
DEPT OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS, MANUBHAI PATEL DENTAL COLLEGE AND HOSPITAL, VISHWAJYOTI ASHRAM, NEAR VIDHYAKUNJ SCHOOL, MUJMAHUDA ,VADODARA , GUJARAT 390011 
 
Primary Sponsor  
Name  DR ANSH THAKKAR  
Address  101, RISHIKESH APT, GIDC COLONY, NR POLICE CHOWKY , UMARGAM, VALSAD 396171 
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 ANSH THAKKAR  MANUBHAI PATEL DENTAL COLLEGE AND HOSPITAL  DEPT OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS, MANUBHAI PATEL DENTAL COLLEGE AND HOSPITAL, VISHWAJYOTI ASHRAM, NEAR VIDHYAKUNJ SCHOOL, MUJMAHUDA ,VADODARA , GUJARAT 390011
Vadodara
GUJARAT 
7567086543

anshvthakar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE(IEC FOR RESEARCH)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ADVANCED-PLATELET RICH FIBRIN (A-PRF)PLACEMENT   POST EXTRACTION ADVANCED-PLATELET RICH FIBRIN(A-PRF) WILL BE PLACED IN THE SOCKET AND THE SOCKET WILL BE SUTURED. 
Intervention  LEUKOCYTE RICH-PLATELET RICH FIBIRN(L-PRF) PLACEMENT   POST EXTRACTION LEUKOCYTE RICH-PLATELET RICH FIBIRN(L-PRF) WILL BE PLACED IN THE SOCKET AND THE SOCKET WILL BE SUTURED.  
Intervention  Nil  Nil 
Comparator Agent  SALINE FLUSHED EXTRACTION SOCKET   POST EXTRACTION SALINE WILL BE FLUSHED AND THE SOCKET WILL BE SUTURED TO KEEP THE PATIENT BLINDED AND UNDER PLACEBO CONTROL 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  i.Patients requiring fixed orthodontic treatment
ii.Good oral hygiene and healthy periodontium
iii.Patients whose treatment plan requires extraction of all 1st premolars
iv.Age group- 15-30 years of age
v.No previous history of orthodontic treatment
 
 
ExclusionCriteria 
Details  i.Patients who do not give consent for the study
ii.Poor oral hygiene
iii.Patients with any deleterious habits (smoking, alcohol, tobacco chewing)
iv.Patients taking medications that could interfere with orthodontic tooth movement (NSAIDs, cortisone, bisphosphonates, anticoagulants and hormones like oestrogen, thyroid).
v.Systemic illnesses like uncontrolled Diabetes mellitus, AIDS, patients on medication like phenytoin, or immunosuppressants.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Evaluate and Compare effect of Advanced-Platelet rich fibrin , Leukocyte rich -Platelet Rich Fibrin and placebo control on orthodontic tooth movement.  Patient will be recalled every month (T1, T2 T3, T4) and study models will be made to check for amount of canine retraction measured from distal surface of canine to mesial surface of 2nd premolar with the help of Digital Vernier Caliper.  
 
Secondary Outcome  
Outcome  TimePoints 
Evaluate and Compare effect of Advanced-Platelet rich fibrin , Leukocyte rich -Platelet Rich Fibrin and placebo control on socket healing and pain control.  Patient will be asked for pain post extraction and recalled every month (T1, T2 T3, T4) and checked for socket healing. 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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   N/A 
Date of First Enrollment (India)   28/07/2025 
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  

        This will be an in-vivo study. 24 patients undergoing orthodontic treatment will be selected for the study. Each participant will be treated with fixed pre-adjusted appliance. The study will be carried out in 2 phases.

        PHASE I :

         The system used will be metal 0.022 x 0.028” slot MBT bracket system. Trans Palatal Arch (TPA) will be given for anchorage. Leveling alignment will be done with a 0.012-in NiTi archwire, 0.014 in NiTi archwire,0.016 in NiTi archwire according to the requirement of the case. A 0.019×0.025-in SS archwire will be placed for one month for torque expression.

        PHASE II :

        Following this, atraumatic extractions of maxillary first premolars will be carried out.

        This study will be a split-mouth, single blinded, prospective, single centre randomized control study conducted for a period of 4 months (T0, T1, T2, T3, T4).

        Blood will be drawn before the extraction procedure and sent for centrifugation. Extraction will be carried out atraumatically by a single operator, once we receive the A-PRF and L-PRF.

        Allocation Method:

        In the first participant, the sites will be allocated as experimental & control using lottery method.

        Therefore, one arch of the patient will be packed with A-PRF in the extraction socket on one side and respective control group on opposite side of the same arch. Whereas contralateral arch will be packed with L-PRF in the extraction socket and control group on the opposite side of this arch. Control group will be flushed with saline in extraction socket. Experimental group will be packed with either A-PRF or L-PRF.

        Hence, each subject will have two experimental and two control quadrants. Experimental groups will be placed diagonal to each other to take care of unequal masticatory forces.

        In the next patient, the quadrants will be changed going clockwise, so suppose A-PRF was in first quadrant in first patient, the A-PRF site would be in second quadrant in second patient, in third quadrant in third patient and so on. This will be continued till the 24th patient going in a clockwise circle.

One circle will be completed in 4 patients and similar 6 circles will be completed in 24 patients.

 

        L-PRF preparation-Using a 5ml syringe, whole venous blood sample will be drawn quickly from the median cubital vein and placed into two sterile tubes (Bello centrifuge tubes, India) without the use of an anticoagulant. These tubes will then be immediately centrifuged at 2,700 rpm (about 400-g centrifugation force, based on our estimations) for 12 minutes in Centrifugation machine (Labtech Dentifuge, Gujarat, India).   

          Preparation of A-PRF -After centrifugation in a manner similar to L-PRF, (1500 RPM for 12 minutes) the middle fraction (A-PRF) will be collected.

        Placement- L-PRF And A-PRF plugs will be placed in the allocated socket using sterile tweezers (GDC, India), and compressed with amalgam condenser. The control group sites will be flushed with saline (Puniska, Gujarat, India). All the sockets will be sutured with 3-0 silk sutures (AQsilk, Karnataka, India)(using simple interrupted suturing technique) to keep the patient blinded about the technique.

        MEASUREMENTS

        The patients will start undergoing treatment with fixed appliances. T0 cast will be recorded post extraction and patients will be given 12mm NiTi closed coil spring (G&H, Franklin, USA) for retraction post extraction (150g force) on 0.019×0.025-in SS arch wire. After that, patient will be recalled every month (T1, T2 T3, T4) and study models will be made to check for amount of canine retraction measured from distal surface of canine to mesial surface of 2nd premolar with the help of Digital Vernier Caliper. (Aerospace, Japan)

        The velocity will be calculated as follows: v = d/t, where v is the velocity of canine movement, d is the amount of this movement in millimetres, and t is 4 months (i.e. velocity will be measured at T4)

 

 
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