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
|
|
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
|
|
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 0.017â€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. |