| CTRI Number |
CTRI/2025/07/090218 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
20/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of Rate of Canine Movement in Upper Arch using Platelet Rich Fibrin |
|
Scientific Title of Study
|
Comparative Evaluation of the Effects of Injectable Platelet Rich Fibrin(i-PRF) on Rate of Maxillary Canine Retraction – A Split Mouth Randomized Trial |
| 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 Himanshu Kumar Sah |
| Designation |
PG student |
| Affiliation |
Chhattisgarh Dental College and Research Institute GE Road Sundra Rajnandgaon CG 491441 |
| Address |
Room no 6 Dept of Orthodontics Chhattisgarh Dental College and Research Institute GE Road Sundra Rajnandgaon CG 491441
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
8380892584 |
| Fax |
|
| Email |
khimanshu2898@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tanusha Mahobia |
| Designation |
Reader |
| Affiliation |
Chhattisgarh Dental College and Research Institute GE Road Sundra Rajnandgaon CG 491441 |
| Address |
Room no 6 Dept of Orthodontics Chhattisgarh Dental College and Research Institute GE Road Sundra Rajnandgaon CG 491441
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
8889679680 |
| Fax |
|
| Email |
tanushamahobia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Himanshu Kumar Sah |
| Designation |
PG student |
| Affiliation |
Chhattisgarh Dental College and Research Institute GE Road Sundra Rajnandgaon CG 491441 |
| Address |
Room no 6 Dept of Orthodontics Chhattisgarh Dental College and Research Institute GE Road Sundra Rajnandgaon CG 491441
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
8380892584 |
| Fax |
|
| Email |
khimanshu2898@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chhattisgarh Dental College and Research Institute GE Road Sundara Rajnandgaon CG 491441 |
|
|
Primary Sponsor
|
| Name |
Dr Himanshu Kumar Sah |
| Address |
Room no. 6 Dept of Orthodontics Chhattisgarh Dental College and Research Institute GE Road Sundara Rajnandgaon CG 491441 |
| 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 Himanshu Kumar Sah |
Chhattisgarh dental college and research institute |
Room No 6
Department of
Orthodontics and
dentofacial orthopedics
Chhattisgarh dental
college and research
institute Sundra GE road
Rajnandgaon
Chhattisgarh 491441
Rajnandgaon
CHHATTISGARH |
8380892584
khimanshu2898@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| EC/NEW/INST/2020/1034 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
No injectable platelet rich fibrin (i-PRF) will be infiltrated in the buccal and palatal submucosa of extraction site and canine retraction will be performed using active tiebacks at T0 (baseline), T1 (after 1 month) and T2 (after 2 months) intervals for 3 months in control group. |
| Intervention |
Experimental group |
3 ml injectable platelet rich fibrin (i-PRF) will be made by centrifugation of patients blood according to standard instructions. 2 ml of i-PRF will be infiltrated in the buccal submucosa and 1 ml of i-PRF in the palatal submucosa of extraction site at T0 (baseline), T1 (after 1 month) and T2 (after 2 months) intervals and canine retraction will be performed using active tiebacks for 3 months in experimental group. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with Class I bimaxillary protrusion and Class II Division 1 malocclusion requiring extraction of maxillary first premolar.
2. Fully erupted permanent dentition (except third molars).
3. Patient with good oral hygiene. |
|
| ExclusionCriteria |
| Details |
1. Smokers.
2. Pregnant women.
3. Patients with impacted or blocked canine.
4. Patients with systemic disease.
5. Coagulation disorders or being treated with anticoagulants.
6. Patients who had previous orthodontic treatment or had radiographic evidence of bone resorption |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rate of canine retraction will compared in the experimental group and control group. |
Rate of canine retraction will be evaluated at T0 (baseline),T1 (after 1 month) and T2 (after 2 months) intervals. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To determine and compare the three-dimensional control (transverse, sagittal and vertical) of canine and molar.
2. To determine gingival and periodontal health of canine and molar.
3. To determine the most suitable technique for clinical usage. |
The study parameter will be evaluated at T0 (baseline), T1 (after 1 month) and T2 (after 2 months). |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/08/2025 |
| 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="1"
Months="6"
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
|
A split-mouth, randomized controlled trial will be conducted using a single-center, single-blinded (outcome assessor), parallel, double-arm design with a 1:1 allocation ratio. A total of 20 patients undergoing fixed appliance therapy who meet the inclusion and exclusion criteria will be recruited for the study. In the experimental group, 2 ml of injectable platelet-rich fibrin (i-PRF) will be infiltrated into the buccal submucosa, and 1 ml of i-PRF will be infiltrated into the palatal submucosa. No i-PRF injection will be administered in the control group. The rate of canine retraction will be assessed and compared between both the groups at three time points: T0 (baseline), T1 (after 1 month), and T2 ( after 2 months). Additionally, three-dimensional control (transverse, sagittal, and vertical), as well as gingival and periodontal health of the canine and molar teeth, will be evaluated and compared using the Plaque Index, Gingival Index, Modified Sulcular Bleeding Index, and Pocket Depth at T0, T1, and T2. The data will be analyzed using appropriate statistical analysis. |