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
|
|
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
|
|
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 |