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CTRI Number  CTRI/2018/08/015257 [Registered on: 09/08/2018] Trial Registered Prospectively
Last Modified On: 16/05/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Can Injecting blood component (PRP) decrease the time taken to move the teeth during braces treatment 
Scientific Title of Study   THE EFFECTS OF LOCALLY INJECTED PLATELET RICH PLASMA ON THE RATE OF TOOTH MOVEMENT DURING MAXILLARY CANINE RETRACTION – A PILOT STUDY 
Trial Acronym  PRP and OTM 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Saraa Angel L 
Designation  Junior Resident  
Affiliation  Centre for Dental Education and Research 
Address  centre for dental education and research (4th floor) all india institute of medical sciences,ansari nagar, New Delhi
centre for dental education and research (4th floor) all india institute of medical sciences
New Delhi
DELHI
110029
India 
Phone  9654047794  
Fax    
Email  saraaangal2011@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr O P Kharbanda 
Designation  Head of the Department 
Affiliation  Centre for Dental Education and Research 
Address  centre for dental education and research (4th floor) all india institute of medical sciences
centre for dental education and research (4th floor) all india institute of medical sciences
New Delhi
DELHI
110029
India 
Phone  9899062144  
Fax    
Email  opk15@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr O P Kharbanda 
Designation  Head of the Department 
Affiliation  Centre for Dental Education and Research 
Address  centre for dental education and research (4th floor) all india institute of medical sciences
centre for dental education and research (4th floor) all india institute of medical sciences
New Delhi
DELHI
110029
India 
Phone  9899062144  
Fax    
Email  opk15@hotmail.com  
 
Source of Monetary or Material Support  
Centre for Dental Education and Research, AIIMS, New Delhi 
 
Primary Sponsor  
Name  Centre For Dental Education and Research 
Address  Centre for Dental Education and Research , All India Institute of Medical Sciences,ansari nagar,New Delhi - 110029 
Type of Sponsor  Research institution and hospital 
 
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 
Saraa Angel L  Centre for Dental Education and Research  Department of Orthodontics and Dentofacial Deformities (4th Floor) Centre For Dental Education and Research, All India Institute of Medical Scieces, Ansari Nagar, New Delhi-110029
New Delhi
DELHI 		 9654047794

saraaangal2011@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Commitee for Post graduate Research All India Institute of Medical Sciences,Ansari nagar, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Response of bone and tooth to local PRP injection  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Normal Physiological tooth movement  normal physiological tooth movement 
Intervention  Platelet Rich Plasma  Local injection of Platelet rich Plasma extracted from patients own blood 0.7ml per site given submucosally once  
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1) Healthy patients with good periodontal condition .
2) Patients within 15 – 35 years irrespective of the gender..
3) Cases of Class II Div I or Bimaxillary protrusion requiring prior bilateral maxillary first premolar extraction.
4) Patient with no significant medical history or metabolic bone disease.
5) Patients with positive informed consent. 
 
ExclusionCriteria 
Details  1) Patients who suffered recent major illness- reduced platelet count.
2) Patients with negative informed consent
3) Patients on regular antibiotics, steroids or anti inflammatory drugs.
4) Non compliant patient with poor oral hygiene 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Acceleration of Orthodontic tooth movement  0,7,21,30,60 days 
 
Secondary Outcome  
Outcome  TimePoints 
Increased Stability of the Tooth in its posiiton after the injection of PRP  0,7,21,30,60 days 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   01/09/2018 
Date of Study Completion (India) 14/05/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="9"
Days="10" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  		 prolonged treatment time has always been a area of concern in both patient and professional point of view. Inspite of the fact of losing interest and motivation to treatment , long treatment time has various adverse effects like enamel demineralization, dental caries, periodontitis which are the aftermath of compromised oral hygiene during a 20-30 months  orthodontic treatment. It also increases the risk of orthodontically induced external root resorption due to prolonged inflammatory reaction. Thus reducing the overall treatment time not only increase the patient compliance but also reduces the adverse effects.Platelet rich plasma(PRP) an autologous platelet concentrate plays a important role in bone metabolism because of its ability to release of various cytokines and growth factors that modulate the metabolism.It is proposed that the Platelet Rich Plasma has a concentration dependent action having a pro-inflammatory action at high concentration. Localized growth factors are hypothesized to bring about acceleration in tooth movement by causing transient osteopenic effect mainly increasing the local inflammatory cytokines through chemotaxis and mesenchymal cell proliferation.Hence the study is aimed to verify the effects of locally injected Platelet Rich Plasma on the rate of tooth movement during maxillary canine retraction. 
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