| CTRI Number |
CTRI/2025/06/088422 [Registered on: 06/06/2025] Trial Registered Prospectively |
| Last Modified On: |
04/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Evaluation of the Effects of Injectable Platelet-Rich Fibrin (PRF) and Its Combination with Low-Intensity Laser Therapy on the Speed of Canine Tooth Movement During Braces Treatment: A Randomized Controlled Trial. |
|
Scientific Title of Study
|
Evaluation of effects of Injectable - Platelet Rich Fibrin and combination of Injectable -Platelet Rich Fibrin & Low Intensity Laser Therapy on the rate of canine retraction - A Randomized Controlled 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 |
Pratiksha Gajanan Wadekar |
| Designation |
Junior resident in the department of orthodontics and dentofacial orthopaedics |
| Affiliation |
Government dental college and hospital ,Nagpur |
| Address |
104,Department of orthodontics and dentofacial orthopaedics,government dental college and hospital,medical square ,ajni road ,440003
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9579335843 |
| Fax |
|
| Email |
pratikshaw249@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Manchanda |
| Designation |
Associate professor |
| Affiliation |
Government dental college and hospital ,Nagpur |
| Address |
104,Department of orthodontics and dentofacial orthopaedics,government dental college and hospital,medical square ,ajni road
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9423188175 |
| Fax |
|
| Email |
drjyotimadaan@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti Manchanda |
| Designation |
Associate professor |
| Affiliation |
Government dental college and hospital ,Nagpur |
| Address |
104,Department of orthodontics and dentofacial orthopaedics,government dental college and hospital,medical square ,ajni road
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9423188175 |
| Fax |
|
| Email |
drjyotimadaan@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital ,medical square ,Ajni road ,Nagpur ,Maharashtra 440003 ,India |
|
|
Primary Sponsor
|
| Name |
Pratiksha Gajanan Wadekar |
| Address |
104,Department of orthodontics and dentofacial orthopaedics,government dental college and hospital,medical square ,ajni road ,Nagpur 440003,Maharashtra, India |
| Type of Sponsor |
Other [Other [Self -funded]] |
|
|
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 Wadekar |
Government Dental College and Hospital, nagpur |
104,Department of orthodontics and dentofacial orthopaedics,government dental college and hospital,medical square ,ajni road ,440003
Nagpur
MAHARASHTRA |
9579335843
pratikshaw249@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Dental College & Hospital, Nagpur INSTITUTIONAL ETHICS COMMITTEE |
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, (2) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Canine Retraction using I- PRF
and combination of I-PRF &
LILT |
After explaining the study to the patient, an informed consent will be taken from the patient before the start of the study.Separators will be placed mesial and distal to first molar for the band placement. After 2 days of
separator placement, molar bands will be customized. Molar Bands will be cemented with Glass Ionomer luting cement.Transpalatal arch will be placed.Preadjusted edgewise MBT brackets of 0.022-inch slot will be bonded and light cured.Alignment and levelling will be initiated. At the end of alignment and levelling final working wire 0.19”x0.25”SS will be inserted.A temporary Anchorage Device(TAD) microimplant will be inserted in between maxillary second premolar and first molar.After Premolar extraction,I-PRF
will be immediately condensed
into extraction socket. Canine retraction will be started by using Nickel-Titanium closed coil spring from the head of micro implant to hook of canine bracket with force of 150gm The laser regimen will be applied on 0, 3, 7, and 14-day intervals in the first month &Thereafter on every 2 weeks till the complete canine retraction |
| Comparator Agent |
canine retraction without using
I-PRF or LILT |
After explaining the study to the patient, an informed consent will be taken from the patient before the start of the study.Separators will be placed mesial and distal to first molar for the band placement. After 2 days of
separator placement, molar
bands will be customized. Molar Bands will be cemented with Glass Ionomer luting cement.Transpalatal arch will be placed.Preadjusted edgewise MBT brackets of 0.022-inch slot will be bonded and light cured.Alignment and levelling will be initiated. At the end of alignment and levelling final working wire
0.19”x0.25”SS will be inserted.A temporary Anchorage Device(TAD) microimplant will be inserted in between maxillary second premolar and first molar.
After Premolar extraction,
I-PRF or LILT not used, Canine retraction will be started by using Nickel-Titanium closed coil spring |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex with age group of 15-25 years.
Angles class I or class II Division 1 malocclusion with Bimaxillary protrusion
|
|
| ExclusionCriteria |
| Details |
Patients with previous history of orthodontic treatment
Patient with canine having dilacerated roots.
Patients with impacted canine.
Patients with sign of gingival or periodontal disease.
Patients with metabolic disorders that leads to bone pathologies.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate effects of Injectable Platelet Rich
Fibrin and combination of Injectable Platelet
Rich Fibrin and Low Intensity Laser Therapy on
the rate of canine retraction |
•T0: at the start of canine retraction.
•T1: at 1 st month after the start of canine retraction.
•T2: at 2 nd month after the start of canine retraction.
•T3: at 3 rd month after the start of canine retraction.
•T4: at the end of canine retraction.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare effects of Injectable Platelet Rich
Fibrin & combination of Injectable Platelet Rich
Fibrin & Low Intensity Laser Therapy on the rate
of canine retraction |
•T0: at the start of canine retraction.
•T1: at 1 st month after the start of canine retraction.
•T2: at 2 nd month after the start of canine retraction.
•T3: at 3 rd month after the start of canine retraction.
•T4: at the end of canine retraction.
|
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
16/06/2025 |
| 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="30" |
|
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
|
Orthodontic treatment is a long process and it is one of the major concerns. To counteract this problem, there is a need to increase the rate of tooth movement. Various methods that can increase the rate of orthodontic tooth movement and reduce the treatment time, includes non-surgical methods like low intensity laser therapy, local injections of prostaglandins, 1, 25(OH)2D3 (the active form of vitamin D3), osteocalcin and Relaxin around the alveolar socket. Among this I-PRF & LILT are noninvasive options for accelerating the orthodontic tooth movement (OTM). Therefore, the aim of this study is to evaluate effects of I-PRF and combination of I-PRF & LILT on the rate of canine retraction. |