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CTRI Number  CTRI/2024/11/076793 [Registered on: 14/11/2024] Trial Registered Prospectively
Last Modified On: 13/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   This is a clinical study to check for faster tooth movement by injecting platelet rich fibrin which is drawn from the patient blood into the extraction space 
Scientific Title of Study   Effect of injectable platelet rich fibrin on en-masse retraction of maxillary anterior teeth-Randomised 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  Kavya G A 
Designation  Post graduate student 
Affiliation  KVG dental college and hospital 
Address  Room no. 7 Department of orthodontics and dentofacial orthopaedic KVG Dental college and hospital Kurunjibhag, Sullia, Dakshina kannada

Dakshina Kannada
KARNATAKA
574327
India 
Phone  8310794598  
Fax    
Email  kavyaga10@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sharath Kumar Shetty  
Designation  Head of the department 
Affiliation  KVG dental college and hospital 
Address  Room number. 7 Department of orthodontics and dentofacial orthopaedic KVG Dental college and hospital Kurunjibhag, Sullia, Dakshina kannada

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9448300500  
Fax    
Email  drsharathshetty45@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sharath Kumar Shetty  
Designation  Head of the department 
Affiliation  KVG dental college and hospital 
Address  Room number. 7 Department of orthodontics and dentofacial orthopaedic KVG Dental college and hospital Kurunjibhag, Sullia, Dakshina kannada

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9448300500  
Fax    
Email  drsharathshetty45@gmail.com  
 
Source of Monetary or Material Support  
KVG Dental college and hospital Kurunjibhag,Sullia,Dakshina Kannnada, Karnataka, India 574327  
 
Primary Sponsor  
Name  kavya G A 
Address  Room no. 7 Department of orthodontics and dentofacial orthopaedic KVG dental college and hospital Kurunjibhag, sullia, dakshina kannada 
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 Kavya G A  KVG dental college and hospital   Room no 7 Department of orthodontics and dentofacial orthopaedic KVG dental college and hospital
Dakshina Kannada
KARNATAKA 		 8310794598

kavyaga10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KVG Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional orthodontic space closure  conventional orthodontic space closure for maxillary anterior en masse retraction over a period of 3 months  
Intervention  Injectable platelet rich fibrin   Injection platelet rich fibrin for for orthodontic space closure of maxillary en masse retraction with 1st premolar extraction over a period of 3 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1. Patients who need fixed appliance with extraction of first
premolars
2. Patients with full permanent dentition (with or without the
third molars)
3. No bleeding on probing, no smokin 
 
ExclusionCriteria 
Details  1. Patients with previous history of fixed orthodontic appliance
treatment
2. Patients who have previous history of systemic diseases
3. Patients with congenitally missing anterior
4. Patients with contraindication for extractions
5. Patients with probing depth more than 3 mm and lack of
sufficient attached gingiva
6. Patient with bleeding disorder 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Rate of space closure in en masse retraction with Injectable platelet rich fibrin   Baseline, 2 week, 5 week,8 week, 12 week 
 
Secondary Outcome  
Outcome  TimePoints 
Amount of space closure every 3weeks  3months  
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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)   10/12/2024 
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="3"
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   10ml of blood will be drawn from brachial vein of patient, drawn blood will be centrifuged for 3minutes with 700rpm to obtain injectable platelet rich fibrin. This obtained injectable platelet rich fibrin will be  injected distobuccal and distopalatal site of canines on both sides, which will be compared with conventional method to check the amount of space closure during en masse retraction of maxillary anterior teeth. 
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