| CTRI Number |
CTRI/2024/04/066097 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
20/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Comparative analysis of administration of Platelet rich plasma (PRP) and
injectable Platelet rich fibrin (IPRF) on acceleration of tooth movement in orthodontic patients |
|
Scientific Title of Study
|
Comparative analysis of administration of Platelet rich plasma (PRP) and
injectable Platelet rich fibrin (IPRF) on acceleration of tooth movement in orthodontic patients -
An In-vivo 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 Pratiksha Batli |
| Designation |
Post Graduate |
| Affiliation |
Faculty of Dental sciences, Ramaiah university |
| Address |
Room no. 8, Dept. of Orthodontics
Second floor,
Ramaiah Dental college,
MSR Nagar, MSRIT Post,
Mathikere
Bangalore
Bangalore
KARNATAKA
590054
India |
| Phone |
9901414887 |
| Fax |
|
| Email |
pratikshabatli110@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashantha GS |
| Designation |
Professor |
| Affiliation |
Faculty of Dental sciences, Ramaiah university |
| Address |
Room no.8, Dept. of Orthodontics
Second floor,
Ramaiah Dental college,
MSR Nagar, MSRIT Post,
Mathikere
Bangalore
Bangalore
KARNATAKA
590054
India |
| Phone |
9886242624 |
| Fax |
|
| Email |
pacchi77@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratiksha Batli |
| Designation |
Post Graduate |
| Affiliation |
Faculty of Dental sciences, Ramaiah university |
| Address |
Roon no. 8, Second floor, Dept. of Orthodontics
Ramaiah Dental college,
Bangalore
Bangalore
KARNATAKA
590054
India |
| Phone |
9901414887 |
| Fax |
|
| Email |
pratikshabatli110@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept. of Orthodontics, Faculty of Dental sciences, Ramaiah University of Applied Sciences
Bangalore |
| Self |
|
|
Primary Sponsor
|
| Name |
Dept of Orthodontics Faculty of Dental Sciences Ramaiah University of Applied sciences |
| Address |
MSR Nagar, MSRIT Post, Mathikere
Bangalore - 560054 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Pratiksha Batli |
Ramaiah Dental Hospital |
Room no. 8, dept. of Orthodontics, Second floor, Ramaiah Dental college and hospital, MSR Nagar, MSRIT Post, Mathikere
560054
Bangalore
KARNATAKA |
9901414887
pratikshabatli110@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee for Human trials of MS Ramaiah University of Applied Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injectable - Platelet rich fibrin |
intraligamentary injection of 0.5ml on experimental site - Distal to canine tooth on buccal aspect, medial to lateral incisor tooth on palatal aspect, medial to central incisor tooth on palatal aspect |
| Intervention |
Platelet Rich Plasma |
intraligamentary injection of 0.5ml on experimental site - Distal to canine tooth on buccal aspect, medial to lateral incisor tooth on palatal aspect, medial to central incisor tooth on palatal aspect |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patients with ClassI bimaxillary protrusion requiring all first premolar extraction for orthodontic treatment |
|
| ExclusionCriteria |
| Details |
Patients under any other medication which affects tooth movement.
Patients with craniofacial anomalies.
Patients with periodontal disease.
Patients with any kind of systemic disease that affects tooth movement.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Acceleration of tooth movement |
every month for four months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| root resorption and tooth vitality |
pre and post intervention |
|
|
Target Sample Size
|
Total Sample Size="13"
Sample Size from India="13"
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 |
|
Date of First Enrollment (India)
|
01/05/2024 |
| 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="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 (Moaffak A. 2019, Sean E. V. 2015, Varella. 2018). Studies have been conducted to evaluate the rate of orthodontic tooth movement following the administration of platelet rich plasma and shown significant results (Aysegul. 2016, Ahmed El-Timamy. 2020, Nakornnoi. 2019, Sibel Akbulut. 2018). A number of studies have been conducted on effect of PRF on tooth movement with significant results (Farshidfar N. 2021, Erdur EA. 2021, Kuter Karakasli. 2021). And study on comparison on effects of IPRF and PRP on osteoblast behaviour and bone tissue formation has been evaluated (Xuzhu Wang. 2017). |