FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/09/036459 [Registered on: 13/09/2021] Trial Registered Prospectively
Last Modified On: 05/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   TO STUDY THE RELATION OF ALKALINE PHOSPHATASE ENZYME ACTIVITY IN GINGIVAL CREVICULAR FUILD WITH THE RATE OF TOOTH MOVEMENT FASTENED BY PLATELET RICH PLASMA INJECTION 
Scientific Title of Study   EVALUATION OF RELATION BETWEEN ALKALINE PHOSPHATASE ACTIVITY IN GINGIVAL CREVICULAR FLUID WITH THE RATE OF TOOTH MOVEMENT ACCELERATED BY PLATELET RICH PLASMA INJECTION - IN VIVO STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR BHARAT KRISHNAN C K 
Designation  POST GRADUATE STUDENT 
Affiliation  FACULTY OF DENTAL SCIENCES, MS RAMAIAH UNIVERSITY OF APPLIED SCIENCES 
Address  DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS, FACULTY OF DENTAL SCIENCES, M S RAMAIAH UNIVERSITY OF APPLIED SCIENCES, GNANAGANGOTHRI CAMPUS, NEW BEL ROAD,BENGALURU

Bangalore
KARNATAKA
560054
India 
Phone  9945475074  
Fax    
Email  bharatckrishnan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR PRASHANTHA G S 
Designation  PROFESSOR and HOD 
Affiliation  FACULTY OF DENTAL SCIENCES, MS RAMAIAH UNIVERSITY OF APPLIED SCIENCES 
Address  DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS, FACULTY OF DENTAL SCIENCES, M S RAMAIAH UNIVERSITY OF APPLIED SCIENCES,GNANAGANGOTHRI CAMPUS, NEW BEL ROAD,BENGALURU

Bangalore
KARNATAKA
560054
India 
Phone  9886242624  
Fax    
Email  pacchi77@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  DR BHARAT KRISHNAN C K 
Designation  POST GRADUATE STUDENT 
Affiliation  FACULTY OF DENTAL SCIENCES, MS RAMAIAH UNIVERSITY OF APPLIED SCIENCES 
Address  DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS, FACULTY OF DENTAL SCIENCES, M S RAMAIAH UNIVERSITY OF APPLIED SCIENCES, GNANAGANGOTHRI CAMPUS, NEW BEL ROAD, BENGALURU

Bangalore
KARNATAKA
560054
India 
Phone  9945475074  
Fax    
Email  bharatckrishnan@gmail.com  
 
Source of Monetary or Material Support  
FACULTY OF DENTAL SCIENCES, MS RAMAIAH UNIVERSITY OF APPLIED SCIENCES,GNANAGANGOTHRI CAMPUS, NEW BEL ROAD,MSR NAGAR,BENGALURU 560054 
 
Primary Sponsor  
Name  DR BHARAT KRISHNAN C K 
Address  DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS, FACULTY OF DENTAL SCIENCES,MS RAMAIAH UNIVERSITY OF APPLIED SCIENCES, GNANAGANGOTHRI CAMPUS, NEW BEL ROAD,BENGALURU 560054 
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 BHARAT KRISHNAN C K  FACULTY OF DENTAL SCINECES, RAMAIAH UNIVERSITY OF APPLIED SCIENCES  ROOM NO:8, DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS,2ND FLOOR,FACULTY OF DENTAL SCIENCES, RAMAIAH UNIVERSITY OF APPLIED SCIENCES,NEW BEL ROAD, MSR NAGAR
Bangalore
KARNATAKA 
9945475074

bharatckrishnan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
THE UNIVERSITY ETHICS COMMITTEE FOR HUMAN TRIALS OF M S RAMAIAH UNIVERSITY OF APPLIED SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Comparator Agent  conventional retraction   conventional retraction using elastics and active tiebacks are done on the control side. 
Intervention  platelet rich plasma  collection of gingival crevicular fluid following platelet rich plasma administration as an adjuvant on the experimental side during retraction phase with the conventional method of retraction 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  class I bimaxillary malocclusion needing all first premolar extractions 
 
ExclusionCriteria 
Details  Patients under any other medication which affects tooth movement
Patients with craniofacial anomalies
Patients with periodontal disease
Patients with any kind of systemic disease that affects tooth movement 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The level of ALP in the GCF of experimental side canine and molar and control side canine is evaluated.  The GCF samples from the experimental canine and molar and control canine will be evaluated for the ALP levels using Human ALP ELISA test kit at T0(baseline), T1(21st day), T2(3rd month). 
 
Secondary Outcome  
Outcome  TimePoints 
1.The rate and amount of tooth movement in Platelet rich plasma administered side and non administered side

2.The anchorage loss on the experiment and non experiment side. 
1.The amount and rate of tooth movement will be measured from the distal surface of canine and mesial surface of the second premolar at T0(before start of retraction), T1(1st month),T2(2nd month),T3(3rd month) and T4(4th month)

2.The lateral cephalogram will be taken at T0(baseline) and
T1(3rd month)to assess the position of molar with respect to any stable landmark 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "14"
Final Enrollment numbers achieved (India)="14" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/09/2021 
Date of Study Completion (India) 17/11/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Fixed orthodontic therapy requires longer duration of treatment, usually about 2-3 years, accompanied by great concerns and risks such as caries, external root resorption and decreased patient compliance. To shorten the duration of treatment time, the concept of accelerated orthodontic tooth movement was introduced. One of the recently introduced agent to locally accelerate the orthodontic tooth movement is Platelet Rich Plasma (PRP). PRP is an autologous concentration of platelets in a small volume of plasma, rich in various growth factors and cytokines which potentiates the ability to stimulate the osteoblastic and osteoclastic activities and can have possible effect on orthodontic tooth movement. Alkaline Phosphatase (ALP) is an enzyme that is secreted during bone formation reflecting the osteoblastic activity. Estimation of ALP may possibly be an indicator of the bone remodelling and therefore an indicator for rate of tooth movement following force application.

This study aims to evaluate the effects of local administration of PRP on the rate of tooth movement by comparison of the ALP levels at the experimental vs control sites and moving unit vs anchoring unit.

The patients will be subjected to experiment based on randomly assigned split mouth design to prevent individual biologic variation. Pre-adjusted edgewise MBT prescription bracket system will be used with 0.022 slot and anchorage reinforcement by auxiliaries like Transpalatal arch and lingual arch or 2nd molar banding will be decided. After levelling and aligning, during the retraction phase, GCF samples will be collected using microcapillary tubes from the experimental site canine and molar and the control site canine to evaluate the baseline levels of ALP. Following this the pharmacological agent platelet rich plasma will be administered in the experimental site canine and GCF samples will be collected at 14 days,21st day and 3rd month post administration to evaluate for ALP levels

 
Close