| 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
|
|
|
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
|
|
|
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) |