| CTRI Number |
CTRI/2025/12/099332 [Registered on: 17/12/2025] Trial Registered Prospectively |
| Last Modified On: |
16/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A study to check the effect of injectable platelet rich fibrin on the speed of canine tooth movement during braces treatment. |
|
Scientific Title of Study
|
Comparison of rate of maxillary canine retraction with and without submucosally administered injectable platelet-rich fibrin (i-prf) among orthodontic cases indicated for first premolar extraction – 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. DHARINI M |
| Designation |
Senior Lecturer |
| Affiliation |
Dayananda sagar college of dental sciences , affiliated to Rajiv Gandhi University of Health Sciences |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics,5TH floor, Dental Block
Dayananda Sagar College of Dental Sciences.
Shavige Malleshwara Hills,
Bangalore- 560 111, Karnataka, India
Kumaraswamy Layout, Bangalore 560 111, Karnataka, India
Bangalore
KARNATAKA
560111
India |
| Phone |
09164198727 |
| Fax |
- |
| Email |
dharinim@dscds.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aravind M |
| Designation |
Professor |
| Affiliation |
Dayananda Sagar college of dental sciences, affiliated to Rajiv Gandhi University of Health Sciences |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics, 5th floor, Dental block
Dayananda Sagar College of Dental Sciences. Shavige Malleshwara Hills, Kumaraswamy Layout, Bangalore - 560 111, Karnataka, India
Dayananda Sagar College of Dental Sciences. Shavige Malleshwara Hills,Kumaraswamy Layout, Bangalore 560 111, Karnataka, India
Bangalore
KARNATAKA
560111
India |
| Phone |
9886111436 |
| Fax |
- |
| Email |
aravindm@dscds.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DHARINI M |
| Designation |
Senior lecturer |
| Affiliation |
Dayananda sagar college of dental sciences, affiliated to Rajiv Gandhi university of health sciences. |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics, 5th floor, Dental block,
Dayananda Sagar College of Dental Sciences.
Shavige Malleshwara Hills, Kumaraswamy Layout, Bangalore 560 111, Karnataka, India
Department of Orthodontics and Dentofacial Orthopaedics, 5th floor, Dental block,
Dayananda Sagar College of Dental Sciences.
Shavige Malleshwara Hills, Kumaraswamy Layout, Bangalore 560 111, Karnataka, India
Bangalore
KARNATAKA
560111
India |
| Phone |
09164198727 |
| Fax |
- |
| Email |
dharinim@dscds.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr DHARINI M |
| Address |
Dayananda Sagar College of Dental Sciences. Shavige Malleshwara Hills, Bangalore- 560111 |
| 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 DHARINI M |
DAYANANDA SAGAR COLLEGE OF DENTAL SCIENCES |
Department of Orthodontics and dentofacial Orthopaedics, 5th floor, Dental block,
Dayananda Sagar College of Dental Sciences. Shavige Malleshwara Hills, Kumaraswamy Layout, Bangalore 560111, Karnataka, India
Bangalore
KARNATAKA |
09164198727
-
dharinim@dscds.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DAYANAND SAGAR COLLEGE OF DENTAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients with requiring extraction of first maxillary premolars for orthodontic treatment, Angles Class II division 1 malocclusion, Angles Class I Bimaxillary protrusion malocclusion. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injectable platelet rich fibrin |
A 10 ml Blood sample will be taken from the patients forearm and collected in a non-silica-coated yellow cap tube of 10 ml. i-PRF is prepared by spinning at 700 rpm for three minutes of centrifugation. The tube obtained after completion of centrifugation shows two different layers with superficial layer being clear liquid PRF and bottom layer being RBCs. The clear fluid about 2ml will be extracted for i-PRF injection, following strict aseptic protocols.
After infiltration with local anaesthesia 0.5 mL of i-PRF will be slowly administered submucosally at each of three sites around the experimental maxillary canine at baseline(T0) once, after collecting the intraoral records, and is followed up to 6 months. |
| Comparator Agent |
local Anaesthesia |
Local anaesthetic infiltration of 0.5 mL lignocaine (1:100 000) will be given on each side. The experimental side will receive an additional i-PRF injection at baseline (T0) . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Age between 18-35 years, requiring extraction of first maxillary premolars for orthodontic treatment, Class 2 division 1, Bimaxillary protrusion cases |
|
| ExclusionCriteria |
| Details |
Patients with horizontal or vertical bone loss history of bone disorders, poor periodontal health, systemic diseases especially blood dyscrasias, pregnancy, and on steroid therapy, severe skeletal dysplasia in all three dimensions and with poor oral hygiene were excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)To assess the rate of maxillary canine retraction in experimental site
administered with i-PRF and control site(not administered with i-PRF) at
different time intervals ( baseline T0- T6).
2) To compare the rate of maxillary canine retraction between experimental site
administered with i-PRF and control site (not administered with i-PRF) at
different time intervals ( baseline T0- T6). |
Evaluated at
T0 baseline, 30 days (T1), at 60 days (T2),at 90 days (T3),at 120 days(T4),at 150 days (T 5) and at 180 days(T6 )
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the rate of maxillary canine retraction within experimental site administered with i-PRF & within control site
(not administered with i-PRF)
at different time intervals ( baseline T0- T6). |
Evaluated at T0-T6
baseline (T0), at 30 days (T1), at 60 days (T2),at 90 days (T3),at 120 days(T4),at 150 days (T 5) & at 180 days(T6). |
To compare the rate of maxillary canine retraction
between male & females. |
Evaluated at T0-T2
baseline (T0), at 30 days (T1), at 60 days (T2). |
|
|
Target Sample Size
|
Total Sample Size="24"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/01/2026 |
| 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="7"
Days="25" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Approval for the study was was obtained from the Institutional Review Board of Dayananda Sagar College of Dental Sciences. Consent will be obtained from subjects participating in the study after explaining the purpose and the procedures involved in the study in a language that is understandable by the participants. All patients will be informed of the PRF injection and applications ,and informed consent form will be obtained to be a part of the study. |