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CTRI Number  CTRI/2018/02/011934 [Registered on: 16/02/2018] Trial Registered Prospectively
Last Modified On: 26/08/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of blood cells on the Speed of tooth Movement 
Scientific Title of Study   Effect of Submucosal injection of Platelet Rich Plasma on the Rate of Canine retraction - A Split Mouth Randomized Clinical Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gayathri M 
Designation  JR-1 
Affiliation  Post Graduate Institute of Dental Sciences, Rohtak 
Address  Department of Orthodontics and Dentofacial Orthopedics, PGIDS
Room no.84, block 2, girls hostel,PGIMS
Rohtak
HARYANA
124001
India 
Phone  9566019091  
Fax    
Email  gayathri.mohan22@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rekha Shatrma 
Designation  Senior professor and head of the department 
Affiliation   
Address  Department of Orthodontics and Dentofacial Orthopedics, PGIDS

Rohtak
HARYANA
124001
India 
Phone  9467784352  
Fax    
Email  rajsringari@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gayathri M 
Designation  JR-1 
Affiliation  Post Graduate Institute of Dental Sciences, Rohtak 
Address  Department of Orthodontics and Dentofacial Orthopedics, PGIDS
Room no.84, block 2, girls hostel,PGIMS
Rohtak
HARYANA
124001
India 
Phone  9566019091  
Fax    
Email  gayathri.mohan22@gmail.com  
 
Source of Monetary or Material Support  
Post graduate Institute of Dental Sciences, Rohtak 
 
Primary Sponsor  
Name  PANDIT BHAGWAT DAYAL SHARMA UNIVERSITY OF HEALTH 
Address  Rohtak, Haryana - 124001, India 
Type of Sponsor  Government medical college 
 
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 Gayathri M  Post graduate Institute of Dental Sciences  Department of orthodontics and Dentofacial Orthopedics, Post graduate Institute of Dental Sciences,
Rohtak
HARYANA 
9566019091

gayathri.mohan22@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, PGIDS, Rohtak  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  healthy patients with dental malocclusion requiring bilateral 1st premolar extraction 
Patients  Patients requiring bilateral extraction of upper 1st premolar,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  Platelet Rich Plasma  Platelet Rich Plasma will be prepared by double centrifugation method from the blood collected from the patients and it will be injected in the buccal vestibule distal to the canine on experimental side 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Patients requiring bilateral extraction of maxillary 1st premolars, with platelet count above 1,00,000 per ml, and good oral hygiene 
 
ExclusionCriteria 
Details  Patients with thrombocytopenia, bleeding or clotting disorders, systemic diseases, presence of any gingival or periodontal diseases, long term drug history, evidence of bone loss, smoking habit and any untreated carious lesion 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Rate of canine retraction measured in millimeters  Measured at 4th, 8th and 12th weeks after injection of PRP
 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="14" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   01/03/2018 
Date of Study Completion (India) 31/03/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Rationale: Several methods have been devised to accelerate the rate of tooth movement during orthodontic treatment which include local administration of cytokines, physical methods and surgical methods. Recently, it has been found that Platelet Rich Plasma (PRP) increases the rate of orthodontic tooth movement. PRP is an autologous concentration of platelets in a small volume of plasma. It has a high concentration of growth factors which include platelet derived growth factors, fibroblast growth factor, vascular endothelial growth factor, epithelial growth factor and few others. These growth factors enhance mitogenesis, angiogenesis, chemotaxis, cell differentiation and bone remodelling.
Aims and Objectives: To evaluate the effect of PRP on rate of tooth movement in canine retraction. Objectives of this study is to evaluate the amount of extraction space closure during canine retraction in experimental and control side and to compare the same.
Setting: Department of Orthodontics and Dentofacial Orthopaedics, PGIDS, Rohtak.
Study Design: Prospective, single blind, split-mouth, randomized clinical study
Time frame: 12 months
Population/participant: Inclusion criteria:- Patients with age between 15-25 years, requiring bilateral extraction of maxillary 1st premolars, with platelet count above 1,00,000 per ml and good oral hygiene. Exclusion Criteria:- Patients with thrombocytopenia (platelet count less than 1,00,000 per ml), clotting or bleeding disorders, systemic diseases, presence of any signs and symptoms of gingival and periodontal diseases, long-term drug history, evidence of bone loss, smoking habit, any untreated carious lesions.
Sample size: a sample size of 12 patients
Method of study: Patients who met the inclusion criteria will be selected for the study. Treatment will be initiated by bonding 0.022” slot MBT straight wire appliance. Space closure will be carried out with 0.017”x 0.025” SS wires using closed coil NiTi springs and Transpalatal Arch- 20gauge(0.9mm) as anchorage unit. 10ml of venous blood sample from each patient will be collected in a sterile test tube. 1ml of 10% Sodium Citrate will be used as anticoagulant. One ml of the whole blood will be sent to the laboratory for the calculation of platelet count. The remaining 9ml of blood will be used for the preparation of PRP. PRP will be prepared by the method of double spin centrifugation. 1ml of PRP will be obtained from which 0.2 ml will be sent to the laboratory for analysis of platelet count and 0.8 ml will be injected submucosally into the buccal vestibular mucosa distal to the canine tooth on the experimental side.
Outcome Measures: The outcome variables will be the rate of canine retraction measured in millimeters.
Statistical Analysis: Data will be checked for normality. If normally distributed then paired t test will be applied. If not normally distributed then wilcoxon signed rank test will be applied.
 
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