| CTRI Number |
CTRI/2024/07/070721 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
15/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Dentistry |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
comparative evaluation of effect of L-PRF and A-PRF on acceleration of tooth movement |
|
Scientific Title of Study
|
Evaluation and comparison of the effect of Leukocyte platelet rich fibrin and
advanced platelet rich fibrin in the rate of orthodontic tooth movement: 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 Deepthi D |
| Designation |
PG Student |
| Affiliation |
M S Ramaiah dental college |
| Address |
Room no. 8, 2nd floor, Department of Orthodontics and Dentofacial Orthopedics, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, Mathikere, Bangalore-560054
Mandya
KARNATAKA
560054
India |
| Phone |
8884959316 |
| Fax |
|
| Email |
deepthi.dwarki@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashantha G S |
| Designation |
Professor and head of the department |
| 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 |
pachhi77@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepthi D |
| Designation |
PG Student |
| Affiliation |
M SRamaiah dental college |
| Address |
Room no. 8, 2nd floor, Department of Orthodontics and Dentofacial Orthopedics, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, Mathikere, Bangalore-560054
Mandya
KARNATAKA
560054
India |
| Phone |
8884959316 |
| Fax |
|
| Email |
deepthi.dwarki@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 Deepthi D |
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 |
8884959316
deepthi.dwarki@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 |
| Comparator Agent |
Advanced-Platelet rich fibrin |
A-PRF clot will be placed in the extraction socket just before the retraction phase and the acceleration in rate of tooth movement will be evaluated for 4 months |
| Intervention |
Leukocyte-Platelet rich fibrin |
L-PRF clot will be placed in the extraction socket 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 1week, after 2week, 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="16"
Sample Size from India="16"
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)
|
10/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/08/2024 |
| 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 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
|
Various studies have been conducted using different pharmacological agents where the rate of tooth
retraction is evaluated(El-Timamy et al., 2020; Erdur et al., 2021; Rashid et al., 2017). Studies have
been conducted to evaluate the rate of orthodontic tooth movement following placement of L-PRF
with conflicting results based on mode of administration (KV Balarama et al.,2023; Reyes Pacheco et
al., 2020; Tehranchi et al., 2018). Studies also have been conducted to evaluated the rate of tooth
movement in wilckodontics followed by bone graft mixed with A-PRF (D et al., 2020). There are no
studies available in literature regarding the comparison of effect of A-PRF and L-PRF when used in plug
form on rate of orthodontic tooth movement. Also, no studies have compared the rate of tooth
movement when extractions were done in the beginning of treatment vs extractions done just before
retraction. |