| CTRI Number |
CTRI/2025/02/081083 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
13/02/2025 |
| 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
|
Comparative evaluation of effect of C-PRF and i-PRF on acceleration of tooth movement |
|
Scientific Title of Study
|
Assessment of the effectiveness of concentrated platelet-rich fibrin (C-PRF)
and injectable platelet-rich fibrin (i-PRF) on the rate of orthodontic tooth movement: a
comparative in-vivo 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 |
T Uttam Kumar |
| Designation |
PG Student |
| Affiliation |
Faculty of Dental Sciences, Ramaiah University of Applied Sciences |
| Address |
Room no. 8, 2nd floor, Department of Orthodontics and Dentofacial Orthopedics, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, Mathikere, Bangalore-560054
Bangalore
KARNATAKA
560054
India |
| Phone |
9885232907 |
| Fax |
|
| Email |
tiruvalliuttam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashantha GS |
| Designation |
Professor |
| Affiliation |
Faculty of Dental Sciences, Ramaiah University of Applied Sciences |
| Address |
Room no. 8, 2nd floor, Department of Orthodontics and Dentofacial Orthopedics, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, Mathikere, Bangalore-560054
Bangalore
KARNATAKA
560054
India |
| Phone |
9886242624 |
| Fax |
|
| Email |
pacchi77@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
T Uttam Kumar |
| Designation |
PG Student |
| Affiliation |
Faculty of Dental Sciences, Ramaiah University of Applied Sciences |
| Address |
Room no. 8, 2nd floor, Department of Orthodontics and Dentofacial Orthopedics, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, Mathikere, Bangalore-560054
Bangalore
KARNATAKA
560054
India |
| Phone |
9885232907 |
| Fax |
|
| Email |
tiruvalliuttam@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Room no. 8, 2nd floor, Department of Orthodontics and Dentofacial Orthopedics, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, Mathikere, Bangalore, India-560054 |
|
|
Primary Sponsor
|
| Name |
Faculty of Dental Sciences Ramaiah University of Applied Sciences |
| Address |
Room no. 8, 2nd floor, Department of Orthodontics and Dentofacial Orthopedics, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, Mathikere, Bangalore-560054 |
| Type of Sponsor |
Other [PRIVATE DENTAL COLLEGE AND HOSPITAL] |
|
|
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 T Uttam Kumar |
Faculty of Dental Sciences, Ramaiah University of Applied Sciences |
Room no. 8, 2nd floor, Department of Orthodontics and Dentofacial Orthopedics, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, Mathikere, Bangalore-560054
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
9885232907
tiruvalliuttam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee for Human trials of M S Ramaiah University of Applied Sciences |
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 |
| Intervention |
Concentrated-Platelet rich fibrin |
C-PRF will be injected intraligamentary just before the retraction phase and the acceleration in rate of tooth movement will be evaluated for 4 months |
| Comparator Agent |
Injectable- Platelet rich fibrin |
i-PRF will be injected intraligamentary just before the retraction phase and the acceleration in rate of tooth movement will be evaluated for 4 months |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Class I Bimaxillary cases needing all 4 extractions
2. Between age group of 14 to 30years |
|
| ExclusionCriteria |
| Details |
1. Patients under any other medication which affects tooth movement
2. Patients with craniofacial anomalies
3. Patients with periodontal disease
4. Patients with any kind of systemic disease that affects tooth movement
5. Patients in pregnancy or lactation
6. Patients with habits of smoking and alcoholism |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Acceleration rate of tooth movement |
At baseline, after 1month, after 2months, after 3months, after 4months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Root resorption & tooth vitality |
Just before intervention & after 4 months |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
17/03/2025 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Various studies have been done using different accelerated orthodontic techniques where the rate of tooth retraction is evaluated(El-Timamy et al., 2020). Studies have been conducted to evaluate the rate of orthodontic tooth movement following the administration of i-PRF and shown significant results.(Erdur et al., 2021) Several studies have shown C-PRF exhibited increase in growth factor release when compared with i-PRF, C-PRF significantly promoted higher gingival fibroblast migration, proliferation, gene expression, and collagen I synthesis (Fujioka-Kobayashi et al., 2020). Currently, there is no literature available that compares the rate of orthodontic tooth movement when using C-PRF administration versus i-PRF administration with the split-mouth technique. Additionally, side effects such as root resorption and tooth vitality have been evaluated in conjunction with assessing the acceleration of tooth movement. |