| CTRI Number |
CTRI/2024/05/067365 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
09/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To compare effects of L-PRF and combination of L-PRF & LILT on the rate of canine retraction |
|
Scientific Title of Study
|
Evaluation of effects of Leukocyte- Platelet Rich Fibrin and combination of Leukocyte -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 |
Priyanka vyankaji Tarde |
| Designation |
Post-Graduate Student |
| Affiliation |
Govt. Dental College and HospitalNagpur |
| Address |
Government Dental College and Hospital Nagpur · Address
Medical College Premises, Medical Square, Nagpur, Maharashtra 440003
NIT Complex Jivan Vihar colony, ridge road, Raghuji nagar ,chhhota tajbagh nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
7083421202 |
| Fax |
|
| Email |
priyatarde2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Santosh J. Chavan |
| Designation |
Associate Professor and Head of department |
| Affiliation |
Government Dental College and Hospital Nagpur |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics Government Dental College and Hospital Nagpur
Medical College Premises Medical Square Nagpur Maharashtra 440003
Department of Orthodontics and Dentofacial Orthopaedics Government Dental College and Hospital Nagpur Medical College Premises Medical Square Nagpur Maharashtra 440003
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9823630486 |
| Fax |
|
| Email |
drsjchavan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka vyankaji Tarde |
| Designation |
Post-Graduate Student |
| Affiliation |
Govt. Dental College and HospitalNagpur |
| Address |
Government Dental College and Hospital Nagpur · Address
Medical College Premises, Medical Square, Nagpur, Maharashtra 440003
NIT Complex Jivan Vihar colony, ridge road, Raghuji nagar ,chhhota tajbagh nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
7083421202 |
| Fax |
|
| Email |
priyatarde2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital Nagpur |
|
|
Primary Sponsor
|
| Name |
Priyanka vyankaji Tarde |
| Address |
Department of Orthodontics & Dentofacial Orthopaedics,Government Dental College and Hospital Nagpur ·
Medical College Premises, Medical Square, Nagpur, Maharashtra 440003 |
| Type of Sponsor |
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 Priyanka Vyankaji Tarde |
Government Dental College and Hospital, nagpur |
Room no.104, Department of Orthodontics and Dentofacial Orthopaedics
Nagpur
MAHARASHTRA |
7083421202
priyatarde2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Dental College and Hospital, nagpur |
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 L- PRF and combination of L-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 0.19â€x0.25â€SS will be inserted.
A temporary Anchorage Device (TAD) microimplant will be inserted in between maxillary second premolar and first molar.
After Premolar extraction,L-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 power arm 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 L-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 0.19â€x0.25â€SS will be inserted.
A temporary Anchorage Device (TAD) microimplant will be inserted in between maxillary second premolar and first molar.
After Premolar extraction, L-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 |
1.Angle class I or class II Division 1 malocclusion with Bimaxillary protrusion
2.Extraction of maxillary 1st premolar as a treatment plan
|
|
| ExclusionCriteria |
| Details |
1.Patients with previous h/o orthodontic treatment
2.Patient with canine having dilacerated roots
3.Patients with impacted canine
4.Patients with sign of gingival periodontal disease.
5.Patients with sign of gingival periodontal disease.
|
|
|
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 Leukocyte Platelet Rich Fibrin and combination of Leukocyte Platelet Rich Fibrin and Low Intensity Laser Therapy on the rate of canine retraction |
1.T0 at the start of canine retraction
2.T1 at 3 months after the start of canine retraction
3.T2 at the end of canine retraction
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare effects of Leukocyte Platelet Rich Fibrin & combination of Leukocyte Platelet Rich Fibrin & Low Intensity Laser Therapy on the rate of canine retraction |
1.T0 at the start of canine retraction
2.T1 at 3 months after the start of canine retraction
3.T2 at the end of canine retraction
|
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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)
|
20/05/2024 |
| 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="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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 10-04-2024 and end date provided 30-03-2025?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
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 L-PRF & LILT are noninvasive options for accelerating
the orthodontic tooth movement (OTM). Therefore, the aim of this
study is to evaluate effects of L-PRF and combination of L-PRF & LILT on
the rate of canine retraction.
|