| CTRI Number |
CTRI/2024/07/070019 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
02/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
This study measures the main outcome of tooth movement during orthodontic treatment using two different types of interventions one is I-PRF and another is L-PRF. |
|
Scientific Title of Study
|
Comparison of two stage Injectable platelet-rich fibrin (I-PRF) to that of Leukocyte-platelet-rich fibrin (L-PRF) followed by Injectable platelet-rich fibrin (I-PRF) on the rate of orthodontic tooth movement during en-masse retraction- 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 |
KAVINKUMAR K A |
| Designation |
POST GRADUATE |
| Affiliation |
NARAYANA DENTAL COLLEGE AND HOSPITAL |
| Address |
NARAYANA DENATL COLLEGE AND HOSPITAL
DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS
ROOM NO 6
CHINTHAREDDYPALEM
NELLORE
Nellore ANDHRA PRADESH 524003 India |
| Phone |
9095757477 |
| Fax |
|
| Email |
kakavinkumar2000@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR MANDAVA PRASAD |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
NARAYANA DENTAL COLLEGE AND HOSPITAL |
| Address |
NARAYANA DENATL COLLEGE AND HOSPITAL
DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS
ROOM NO 6
CHINTHAREDDYPALEM
NELLORE
Nellore ANDHRA PRADESH 524003 India |
| Phone |
9440976666 |
| Fax |
|
| Email |
mandavabruno9@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
KAVINKUMAR K A |
| Designation |
POST GRADUATE |
| Affiliation |
NARAYANA DENTAL COLLEGE AND HOSPITAL |
| Address |
NARAYANA DENATL COLLEGE AND HOSPITAL
DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS
ROOM NO 6
CHINTHAREDDYPALEM
NELLORE
Nellore ANDHRA PRADESH 524003 India |
| Phone |
9095757477 |
| Fax |
|
| Email |
kakavinkumar2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS
NARAYANA DENTAL COLLEGE AND HOSPITAL
Room no 6
CHINTHAREDDYPALEM
NELLORE
ANDHRA PRADESH 524003 |
|
|
Primary Sponsor
|
| Name |
KAVINKUMAR K A |
| Address |
NARAYANA DENTAL COLLEGE AND HOSPITAL
CHINTHAREDDYPALEM
NELLORE 524003 |
| 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 KAVINKUMAR K A |
NARAYANA DENTAL COLLEGE AND HOSPITAL |
DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS
SECOND FLOOR ROOM NO-7 CHINTHAREDDYPALEM
NELLORE 524003 Nellore ANDHRA PRADESH |
9095757477
kakavinkumar2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE NARAYANA DENTAL COLLEGE AND HOSPITAL |
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 |
| Intervention |
Injectable platelet rich fibrin (I-PRF)
leukocyte-platelet-rich fibrin (L-PRF) |
Injectable platelet rich fibrin (I-PRF) is a rich source of platelets during bone healing and provides an increased concentration of gingival crevicular fluid (GCF). Wang et al reported that I-PRF affected osteoblastic behaviour remarkably by influencing its migration, proliferation, and differentiation. This promotes cellular activity and accelerates bone turnover and healing.4
leukocyte-platelet-rich fibrin (L-PRF) has been termed as the second-generation platelet concentrate. The L-PRF composed of a 3- dimensional fibrin matrix that traps a variety of blood cells. The L-PRF is enriched with autologous platelets, growth factors, cytokines, and leukocytes that direct the various cells in local tissue remodelling by promoting extracellular matrix synthesis, cell proliferation and differentiation, angiogenesis, and chemotaxis.
|
| Comparator Agent |
Injectable platelet rich fibrin (I-PRF) vs control group
leukocyte-platelet-rich fibrin (L-PRF) vs control group
Injectable platelet rich fibrin (I-PRF) & leukocyte-platelet-rich fibrin (L-PRF) vs control group |
Injectable platelet rich fibrin (I-PRF) is a rich source of platelets during bone healing and provides an increased concentration of gingival crevicular fluid (GCF). Wang et al reported that I-PRF affected osteoblastic behaviour remarkably by influencing its migration, proliferation, and differentiation. This promotes cellular activity and accelerates bone turnover and healing.
leukocyte-platelet-rich fibrin (L-PRF) has been termed as the second-generation platelet concentrate. The L-PRF composed of a 3- dimensional fibrin matrix that traps a variety of blood cells. The L-PRF is enriched with autologous platelets, growth factors, cytokines, and leukocytes that direct the various cells in local tissue remodelling by promoting extracellular matrix synthesis, cell proliferation and differentiation, angiogenesis, and chemotaxis. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy individuals of both genders in the age group of 18 to 30 years.
2. Class I malocclusion with bimaxillary protrusion with average growth pattern.
|
|
| ExclusionCriteria |
| Details |
1. Patients with systemic diseases like Bronchial Asthma, Hypertension, Diabetes, Epilepsy, Congenital heart disease, chronic liver disease, Juvenile Rheumatoid Arthritis, G-6PD deficient individuals, Gastrointestinal problems, Bleeding disorders.
2. Pregnant patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure the rate of tooth movement. |
T0 (at the start of retraction)
T1 (2nd week)
T2 (4th week)
T3 (8th week)
T4 (12th week)
T5 (16th week) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To measure the outcome of pain, at the time of tooth movement. |
T0 (at the start of retraction)
T1 (2nd week)
T2 (4th week)
T3 (8th week)
T4 (12th week)
T5 (16th week) |
|
|
Target Sample Size
|
Total Sample Size="32" Sample Size from India="32"
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)
|
15/07/2024 |
| 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="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
|
INTRODUCTION:
It
is common that the time period to complete the orthodontic treatment varies from the minimum of 18 months to the maximum of 36 months.1 Prolonged
orthodontic treatment can be associated with complications such as poor patient
compliance, poor oral hygiene which leads to gingival problems, decreased
patient satisfaction and iatrogenic effects such as white spot lesions,
external root resorption and possibly loss of
teeth.2 Why should we wait such a long period for the treatment to
be completed?
Thus, finding a method to accelerate orthodontic treatment (OTM) that is safe and predictable with patient compliance which does not
compromise the treatment result, remains at the priority in research and
innovation in the field of orthodontics.3
Many
clinical trials have established to decrease the duration of orthodontic treatment with
different methods by modifying the biological response of tissue including
surgical, pharmaceutical, physical, laser, electromagnetic and other methods.1,4
Platelet-based
preparations from the patient’s blood provide a safe alternative to commercially
available bioactive materials.4
PRF,
a completely autologous fibrin matrix, was developed as a second generation
platelet concentrate without the addition of anticoagulants
and additives at lower centrifugation speeds. PRF is easily
applied, minimally invasive, repeatable, autogenous, low cost, and a complication avoiding procedure.1
Injectable
platelet rich fibrin (i-PRF) is a rich source of platelets
during bone healing and provides an increased concentration of gingival
crevicular fluid (GCF). Wang et al reported
that i- PRF affected
osteoblastic behaviour remarkably by influencing its migration, proliferation,
and differentiation. This promotes
cellular activity and accelerates bone turnover and healing.4
The
leukocyte-platelet-rich fibrin (L-PRF) has been
termed as the second-generation platelet concentrate. The L-PRF composed of a
3- dimensional fibrin matrix that traps a variety of blood cells. The L-PRF is
enriched with autologous platelets, growth factors, cytokines, and leukocytes
that direct the various cells in local tissue remodeling by promoting extracellular matrix synthesis, cell
proliferation and differentiation, angiogenesis, and chemotaxis.5
Need for study:
It has been already proven
that both i-PRF and
L- PRF accelerates orthodontic tooth movement but the maximum effect is seen in first 6 weeks. The
purpose of this study is to compare whether a two stage injectable platelet rich fibrin
(i-PRF) provides extended and faster
orthodontic treatment compared to that of Leukocyte-platelet- rich fibrin
followed by injectable platelet rich fibrin (i-PRF) during en-masse retraction. It also gives a direct comparison of the effect of i-PRF
and L-PRF on the rate of orthodontic
tooth movement in the first stage |