| CTRI Number |
CTRI/2024/04/065362 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
05/04/2024 |
| 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
|
TO KNOW THE AMOUNT OF CANINE MOVEMENT AFTER LOCAL INJECTION OF INJECTIBLE PLATELET RICH FIBRIN. |
|
Scientific Title of Study
|
Efficacy of Injectable Platelet Rich Fibrin on the rate of Canine distalization: A split mouth study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Nikita Navgire |
| Designation |
Post graduate student |
| Affiliation |
Rural Dental College |
| Address |
302, Department of orthodontics
Rural Dental College, Pravara Institute of Medical Sciences, Loni
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
7276667919 |
| Fax |
|
| Email |
nikita.navgire@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shubhangi Mani |
| Designation |
Professor |
| Affiliation |
Rural Dental College |
| Address |
302, Department of Orthodontics,
Rural Dental College, Pravara Institute of Medical Sciences, Loni
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9822772099 |
| Fax |
|
| Email |
drshubhangimani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Nikita Navgire |
| Designation |
Post graduate student |
| Affiliation |
Rural Dental College |
| Address |
302, Department of Orthodontics
Rural Dental College, Pravara Institute of Medical Sciences, Loni
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
7276667919 |
| Fax |
|
| Email |
nikita.navgire@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rural Dental College, Pravara Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Dr Nikita Navgire |
| Address |
Rural Dental College, Pravara Institute of Medical Sciences |
| Type of Sponsor |
Other [self] |
|
|
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 Nikita Navgire |
Rural Dental College |
Department of Orthodontics, 302
Ahmadnagar
MAHARASHTRA |
7276667919
nikita.navgire@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, PRAVARA INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 3||Administration, (2) ICD-10 Condition: K03||Other diseases of hard tissues ofteeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INJECTABLE PLATELET RICH FIBRIN |
Injectable Platelet-Rich Fibrin (PRF) is a biomedical product derived from the patients own blood that is used in various medical and dental procedures. PRF is a concentrate of platelets, fibrin, and various growth factors that play a crucial role in tissue repair and regeneration.
6 months study |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE
6 months |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Class I bimax cases requiring first premolar extraction with absolute anchorage.
2. Class II crowding cases requiring first premolar extraction with absolute anchorage.
3. Class II division 1, camouflage cases requiring first premolar extraction with absolute anchorage.
|
|
| ExclusionCriteria |
| Details |
1. Patients with bone metabolic and blood disorders.
2. Patients with mental disability.
3. Patients with congenital deformity of Oro-Facial structures.
4. Chronic ulcers in oral cavity.
5. Chronic Periodontitis.
6. Facial asymmetry
7. Patients with systemic or chronic debilitating disease that could interfere with bone remodeling.
8. Patients on long-term systemic corticosteroids, calcium channel blockers, antibiotics, bisphosphonates. Or any other medications that could adversely affect the development of the jaws and teeth and subsequent tooth movement.
9. Patients with craniofacial deformities
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Acceleration of orthodontic tooth movement and thus reduction in treatment duration. |
T0- at baseline
T1- at 30 days
T2- at 60 days
T3- at 90 days
T4- at 120 days
T5- at 150 days
T6- at 180 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ACHIEVING SPACE CLOSURE |
T0- at baseline
T1- at 30 days
T2- at 60 days
T3- at 90 days
T4- at 120 days
T5- at 150 days
T6- at 180 days. |
|
|
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 4 |
|
Date of First Enrollment (India)
|
16/04/2024 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
PRF
is easily applied, minimally invasive, repeatable, autogenous, low cost, and a
complication avoiding procedure. The
purpose of this study was to investigate the efficiency of injectable PRF (i-PRF)
on the maxillary canine distalizaton rate. We hypothesized that i-PRF
application would accelerate the rate of tooth movement and could decrease the
duration of orthodontic treatment. |