| CTRI Number |
CTRI/2018/04/013181 [Registered on: 11/04/2018] Trial Registered Prospectively |
| Last Modified On: |
10/04/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Platelet rich plasma for acceleration of tooth movement |
|
Scientific Title of Study
|
Effect of a submucosal injection of Platelet Rich Plasma on the the rate of orthodontic tooth movement - A split mouth,randomised controlled trial |
| Trial Acronym |
PRP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Asavari Desai |
| Designation |
Reader |
| Affiliation |
Manipal College of Dental Sciences |
| Address |
Light house hill road
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
09483363045 |
| Fax |
|
| Email |
desaiasavari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Asavari Desai |
| Designation |
Reader |
| Affiliation |
Manipal College of Dental Sciences |
| Address |
Light house hill road
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
09483363045 |
| Fax |
|
| Email |
desaiasavari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asavari Desai |
| Designation |
Reader |
| Affiliation |
Manipal College of Dental Sciences |
| Address |
Light house hill road
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
09483363045 |
| Fax |
|
| Email |
desaiasavari@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Asavari Desai |
| Address |
Department of Orthodontics,
Manipal College of Dental Sciences,Mangalore 575001,Karnataka. |
| Type of Sponsor |
Private 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 |
| Asavari Desai |
Manipal college of dental sciences |
Department of Orthodontics,Room no 6,
Light House Hill road,
Mangalore - 575001
Dakshina Kannada
KARNATAKA |
09483363045
desaiasavari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with varying degrees of severity of malocclusion and requiring extraction of first premolars scheduled to undergo fixed orthodontic treatment, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
NIL |
| Intervention |
Submucosal injection of Platelet Rich Plasma |
0.8 ml of the PRP will be injected at the target site |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with bimaxillary dentoalveolar protrusion
Scheduled to undergo extraction of 1st premolars |
|
| ExclusionCriteria |
| Details |
Subjects with blood dyscrasias and a periodontally compromised dentition will not be considered. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Accelerated rate of orthodontic tooth movement |
4,8,12,16 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Shorter duration of treatment |
4,8,12,16 weeks |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 1 |
|
Date of First Enrollment (India)
|
16/04/2018 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The long duration of orthodontic treatment poses as a major deterrent for several potential orthodontic patients.Hence,accelerated orthodontics has been an area of great interest for researchers and clinicians alike.Over the years, many methods have been developed to expedite the treatment duration.Recently,a novel idea of using autologous Platelet Rich Plasma(PRP) was put forth by Eric Liou.This technique has so far been assessed only in animal studies with very promising results. Empirical evidence suggests it is effective in humans as well but there is a need for more extensive studies.Keeping this in mind,this split mouth,RCT trial was taken up. 10 subjects of either gender,with bimaxillary dentoalveolar protrusion and requiring therapeutic extraction of 1st premolars will be included in the study. 10 ml of the patient’s blood will be extracted and subjected to centrifugation in order to prepare the PRP. 0.8 ml of this PRP will be injected at the target site ie distal to the canine,prior to retraction of anterior teeth. The rate of tooth movement on both sides of the maxillary arch will beassess and compared by making impressions of the arch,at every monthly patient appointment.This will be done for a period of 4 months. |