| CTRI Number |
CTRI/2024/05/067851 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
27/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Two different treatments methods with Platelet fibrin and Laser to see which one speeds up the process of moving canine teeth in orthodontic patients. |
|
Scientific Title of Study
|
Comparison of platelet rich fibrin (PRF) and low-level laser therapy (LLLT) on rate of orthodontic tooth movement during canine retraction- A split-mouth randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Puja Priya |
| Designation |
PG student |
| Affiliation |
Bharati Vidyapeeth Deemed University Dental College and Hospital, Navi Mumbai, |
| Address |
Room Number -138, First Floor,
Department of Orthodontics and Dentofacial Orthopaedics
Bharati Vidyapeeth Deemed to be University Dental College and Hospital,
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9053419388 |
| Fax |
|
| Email |
puja.priya.15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harsh Mishra |
| Designation |
Associate Professor |
| Affiliation |
Bharati Vidyapeeth Deemed University Dental College and Hospital, Navi Mumbai, |
| Address |
Room- 138, First Floor,
Department of Orthodontics and Dentofacial Orthopedics
Bharati Vidyapeeth Deemed to be University
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8451840579 |
| Fax |
|
| Email |
dr.mishraharsh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Puja Priya |
| Designation |
PG student |
| Affiliation |
Bharati Vidyapeeth Deemed University Dental College and Hospital, Navi Mumbai, |
| Address |
Room Number -138, First Floor,
Department of Orthodontics and Dentofacial Orthopaedics
Bharati Vidyapeeth Deemed to be University Dental College and Hospital,
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9053419388 |
| Fax |
|
| Email |
puja.priya.15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Deemed to be University Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai 400614 |
|
|
Primary Sponsor
|
| Name |
Dr Puja Priya |
| Address |
Room Number -138, First Floor,
Department of Orthodontics and Dentofacial Orthopaedics, Bharati Vidyapeeth Deemed to be University Dental College and Hospital, Sector-7, CBD Belapur, Navi Mumbai- 410210 |
| 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 Harsh Mishra |
Bharati Vidyapeeth Dental Hospital, Navi Mumbai |
Room- 138, First Floor,
Department of Orthodontics and Dentofacial Orthopedics
Raigarh
MAHARASHTRA |
02227564654
022027564655
drmishraharsh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Biomedical and Health Research |
Approved |
|
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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 |
| Intervention |
Canine retraction |
Canine retraction using niti closed coil spring on 0.018 AJ wilcock wire. Retraction measured at T0,T1,T2,T3,T4,T5. Study will complete in 56 days. |
| Comparator Agent |
Platelet rich fibrin, Low level laser therapy |
PRF plug is 2nd generation PRP. It will be autologous, and will be generated by centrifugation in lab.
Low level laser for faster orthodontic tooth movement, a semi-conductor diode laser of wavelength 940nm ± 10nm will be used at T0,T1,T2,T3,T4 (56th day).
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Both |
| Details |
Presence of permanent dentition with mild crowding.
Patients having Class I molar relationship bilaterally.
Indication of extraction of 1st premolars bilaterally in the treatment plan.
Good oral hygiene. |
|
| ExclusionCriteria |
| Details |
Previous orthodontic treatment
Underlying periodontal disease or TMJ disorder
Syndromic patient.
Mixed dentition patients
Missing or impacted tooth |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Tooth movement increase, |
T0 On the day of extraction
T1 7days after extraction
T2 14 days after extraction
T3 28 days after extraction
T4 42 days after extraction
T5 56 days after extraction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| IL-1 beta appearance in Platelet rich fibrin and Low level laser site |
T0 On the day of extraction
T1 7days after extraction
T2 14 days after extraction
T3 28 days after extraction
|
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
03/06/2024 |
| Date of Study Completion (India) |
16/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Treatment duration is one of the prime concerns for patients before starting orthodontic treatment. Various treatment approaches have been tried for acceleration of orthodontic treatment. This study will be comparing between pharmacological method using PRF and physical method using LLLT therapy. Platelet rich fibrin (PRF) has been defined as the 2nd generation platelet rich protein (PRP) where autologous platelets and leukocytes are present in a complex fibrin matrix to accelerate the healing of soft and hard tissue, and accelerate tooth movement. Low Level Laser Therapy (LLLT) also known as Photo-biomodulation is a low powered laser (10mW–1W) with a wavelength of (650 -980nm). Both PRF clot and LLLT can speed up the rate of orthodontic tooth movement. However, the overall quality of evidence ranged from low to very low and the clinical significance of the obtained statistically significant differences is questionable. Hence more precise studies are needed to know which one is faster and more effective among the two so that clinicians can routinely use it in clinical practice as both process will have good patient acceptance. One of the most important cytokines that appears at initial stage of orthodontic tooth movement is IL-1beta. This study will also compare the levels of IL-1beta in both the experimental sites for better understanding at cellular level.
Null hypothesis (H0): There is no difference in the tooth movement between the PRF method and LLLT method. Alternate hypothesis (H1): There is a difference in the tooth movement between the PRF and LLLT method. |