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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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

 
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