| CTRI Number |
CTRI/2020/08/027212 [Registered on: 18/08/2020] Trial Registered Prospectively |
| Last Modified On: |
31/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the effects of injection of Platelet-rich plasma (Blood component of the same patient)in gums on the speed of tooth movement in patients under orthodontic treatment. |
|
Scientific Title of Study
|
Effect of Platelet rich plasma injection for accelerating orthodontic tooth movement in canine retraction cases - A Randomised Controlled Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kanchan Narkhede |
| Designation |
Postgraduate Student |
| Affiliation |
Govenment Dental College And Hospital ,Nagpur |
| Address |
104,Department of Orthodontics And Dentofacial Orthopedics Government Dental College Medical square Hanuman Nagar Nagpur 440003
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9765270888 |
| Fax |
|
| Email |
kanchananarkhede3125@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Wasundhara Bhad |
| Designation |
Professor and H.O.D |
| Affiliation |
Government Dental College and Hospital, Nagpur |
| Address |
Department of Orthodontics And Dentofacial Orthopaedics first floor, Government Dental College and Hospital, Nagpur 440003
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9890227819 |
| Fax |
|
| Email |
wasundharabhad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kanchan Narkhede |
| Designation |
Postgraduate Student |
| Affiliation |
Govenment Dental College And Hospital ,Nagpur |
| Address |
Room No.104 Department of Orthodontics And Dentofacial Orthopedics Government Dental College GMC campus Medical square Hanuman Nagar Nagpur 440003
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9765270888 |
| Fax |
|
| Email |
kanchananarkhede3125@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthodontics and Dentofacial Orthopedics, Government Dental College, Nagpur |
|
|
Primary Sponsor
|
| Name |
Government Dental College and Hospital Nagpur |
| Address |
Government Medical College College Campus,Hanuman nagar Medical square Nagpur 440003 |
| Type of Sponsor |
Other [Government Dental College and Hospital Nagpur] |
|
|
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 Kanchan Narkhede |
Government Dental College and Hospital, Nagpur |
Room no. 104 , Department of Orthodontics And Dentofacial Orthopedics Government Dental College and Hospital, Nagpur 440003
Nagpur
MAHARASHTRA |
9765270888
kanchananarkhede3125@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Dental College And Hospital Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
No Prp will be injected |
| Intervention |
Platelet rich plasma (PRP) |
Injecting prp through attached gingiva around canine tooth for accelerating tooth movement . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients indicated for orthodontic treatment with extraction of 1st premolars of both sides.
2. Patients indicated for fixed mechanotherapy. |
|
| ExclusionCriteria |
| Details |
1. Patients with systemic disease.
2. Patients on Non-steroidal anti-inflammatory therapy/
vitamin D derivatives
3. Periodontally compromised patients.
4. Impacted canines.
5. Canines with dilacerated roots. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Asses the rate of canine tooth movement |
Baseline, 3 months,6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
07/09/2020 |
| 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="1"
Months="6"
Days="5" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Orthodontic tooth movement is described as a process of
continuous remodeling of tissues surrounding the root. This
remodelling takes place under the mechanical forces applied during
orthodontic treatment. One of the major concerns of orthodontic treatment is its longer
duration. To counteract this problem, there has occurred a need to
increase the rate of tooth movement. Accelerating orthodontic
tooth movement has long been desired for its multiple potential
benefits, including shorter treatment duration, reduced side effects
(such as oral hygiene-related problems, root resorption, and open
gingival embrasure spaces), enhanced envelope of tooth movement,
differential tooth movement, and improved posttreatment
stabilityâ€. Various methods that can increase the rate of orthodontic tooth
movement and reduce the treatment time, include non-surgical
methods like low-intensity laser therapy, local injections of
prostaglandins, 1, 25(OH)2D3 (the active form of vitamin D3),
osteocalcin and relaxin around the alveolar socket. other
methods as electric stimulation and resonance vibration have
been tried. Surgical methods mainly include corticotomy -facilitated
tooth movement. Platelet-rich plasma (PRP) is an autologous component of blood with
a high concentration of platelets and has shown to accelerate
orthodontic tooth movement. Platelets, in turn, have α-granules which are the source for many growth factors and the amount of
which is higher in PRP when compared to serum. Due to the
presence of a large amount of these growth factors within the PRP
there is faster bone repair and acceleration of tooth. As such, PRP
contains not only a high level of platelets but also the full
complement of clotting factors and secretory proteins. The seven
known growth factors in PRP are Platelet-derived growth factor as
PDGFαα, PDGFαβ, PDGFββ, transforming growth factor-beta-TGF-β1,
TGF-β2, Vascular endothelial growth factor (VEGF) and epithelial
growth factor (EGF). Platelet-derived growth factor (PDGF) is released upon activation of
osteoblasts, results in an increase of new bone formation. PDGF
initially stimulates bone resorption and stimulates the proliferation
and chemotaxis of osteoblasts. Thus, functions as an anabolic factor
in bone metabolism. Vascular endothelial growth factor (VEGF), is an angiogenic
mediator, is believed to play a critical role in skeletal development
by enhancement of angiogenesis. TGF can stimulate both osteoblastic and osteoclastic activities.
PRP along with growth factors also have a rich content of cytokines
that have a major role during orthodontic tooth movement
throughout mediating differentiation, activation, and survival of all
bone cells supported the idea that PRP could have a possible effect
on orthodontic tooth movement. As PRP includes a patient’s own platelets, the risk of transmissible
diseases and adverse reactions is reduced making PRP a safe and
efficient method of accelerating orthodontic tooth movement. To simulate the effects of surgical insult without surgery, the local
injection of cytokines or hormones could be a substitute for surgical insults, but it is not practical clinically due to its systemic
effects and the need for frequent injections. Injection of autologous platelet-rich plasma (PRP) could be a better substitute for bone
surgery. |