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CTRI Number  CTRI/2024/04/066280 [Registered on: 25/04/2024] Trial Registered Prospectively
Last Modified On: 24/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Accelerated orthodontics with Vitamin D and Injectable Platelet Rich Fibrin 
Scientific Title of Study   Comparison and Evaluation of The Rate of Tooth Movement between Vitamin D and Injectable Platelet Rich Fibrin A Randomised Controlled Trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nazleen Valerie Vas 
Designation  Post-graduate student 
Affiliation  Saveetha Dental College and Hospitals 
Address  Department of Orthodontics Saveetha Dental College Poonamallee High Road Opposite Aravind Eye Hospital Poonamallee-Chennai

Chennai
TAMIL NADU
600077
India 
Phone  8748879783  
Fax    
Email  152108002.sdc@saveetha.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Navaneethan R 
Designation  Professor 
Affiliation  Saveetha Dental College and Hospitals 
Address  Department of Orthodontics Saveetha Dental College Poonamallee High Road Opposite Aravind Eye Hospital Poonamallee-Chennai

Chennai
TAMIL NADU
600077
India 
Phone  8748879783  
Fax    
Email  navaneethan@saveetha.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nazleen Valerie Vas 
Designation  Post-graduate student 
Affiliation  Saveetha Dental College and Hospitals 
Address  Department of Orthodontics Saveetha Dental College Poonamallee High Road Opposite Aravind Eye Hospital Poonamallee-Chennai

Chennai
TAMIL NADU
600077
India 
Phone  8748879783  
Fax    
Email  152108002.sdc@saveetha.com  
 
Source of Monetary or Material Support  
Dr. Nazleen Valerie Vas(self-funded) 
 
Primary Sponsor  
Name  Dr. Nazleen Valerie Vas 
Address  Department of Orthodontics Saveetha Dental College Poonamallee High Road Opposite Aravind Eye Hospital Poonamallee, Chennai 
Type of Sponsor  Other [Self-funded] 
 
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 Nazleen Vas  Saveetha Dental College and Hospitals  Department of Orthodontics Saveetha Dental College and Hospitals Poonamallee High Road Opposite Aravind Eye Hospital Poonamllee Chennai
Chennai
TAMIL NADU 
8748879783

152108002.sdc@saveetha.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethical Committee  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 
Intervention  50 pg/0.2 ml Vitamin D  0.2 ml of the Vitamin is injected via intra-ligamentary mode in the distobuccal, mid-distal and distopalatal line angles each, at an interval of 30 days at 3 time points. The contralateral side of the mouth receives intraligamentary administration of saline at the same sites and time points. 
Comparator Agent  Injectable Platelet Rich Fibrin(i-PRF)  0.2ml of i-PRF is injected via intra-ligamentary mode in the distobuccal, mid-distal and distopalatal line angles each, at an interval of 30 days at 3 time points. The contralateral side of the mouth receives intraligamentary administration of saline at the same sites and time points. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  Patients requiring Mini-implant assisted retraction of the Maxillary Canines using MBT prescription with an 0.022 slot and on a 0.019" x0.025" Stainless Steel archwire
Adults between 18 years and 35 years
No systemic illness, absence of bone metabolic disorders.
Periodontally healthy subjects.
Good oral hygiene.
 
 
ExclusionCriteria 
Details  Patients unwilling to participate in the study.
Patients with a history of anemia, blood loss or vascular diseases.
Patients with history of smoking
Patients on long term use of steroids, bisphosphonates and NSAIDS.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Canine retraction in mm
 
Day of the intervention(T0)
4 weeks from T0 (T1)
8 weeks from T0 (T2)
12 weeks from T0 (T3) 
 
Secondary Outcome  
Outcome  TimePoints 
Canine rotation in degrees  T0 and T3 
Pain experience using a Visual Analogue Scale  T0, 24 hours from T0, 1 week from T0 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   06/05/2024 
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="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [navaneethan@saveetha.com].

  6. For how long will this data be available start date provided 17-10-2024 and end date provided 18-09-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Aim: To determine and compare the effects of local injection of Calcitriol and injectable platelet-rich fibrin on the rate of Canine retraction.

Objectives:
1. To evaluate the retraction of Canine in mm 

2. To evaluate change in Canine rotation in degrees 

3. To study the pain experience between the 2 groups


Methods: 

Sample Size Calculation was done based on the statistical evaluation of a previous study performed by Erdur et al in 2021(Erdur et al., 2021). The Sample calculation was done using G-power software with a power of 95%. A sample of N=5 quadrants (n=5/group) was obtained, however, based on the advice of the SRB board,  keeping attrition and bias due to the small sample size into consideration, a final sample size of 10 was decided upon (n=10/group).

Inclusion Criteria 

Patients requiring Mini-implant assisted retraction of the Maxillary Canines using MBT prescription with an 0.022 slot and on a 0.019" x0.025" Stainless Steel Archwire

●Adults between 18 years and 35 years

● No systemic illness, or absence of bone metabolic disorders. 

● Periodontally healthy subjects. 

● Good oral hygiene. 


Exclusion Criteria 

● Patients unwilling to participate in the study. 

● Patients with a history of anemia, blood loss, or vascular diseases. 

● Patients with a history of smoking 

● Patients on long-term use of steroids, bisphosphonates, and NSAIDs.


A split-mouth randomized clinical trial was planned. Based on the selection criteria, the patients included in this study required extraction of the first maxillary premolars. The extractions were carried out a minimum of a month before the start of this study, to avoid the interference of the regional acceleratory phenomenon (RAP). The patients were undergoing fixed appliance therapy with 0.22 Metal MBT brackets (AO mini master standard edgewise, USA) and were at the end of the Leveling and Aligning stage and canine retraction was carried out on 0.019 x 0.025 Stainless Steel archwire. To ensure absolute anchorage, mini-implants(8mm x 1.5mm, SK Surgical, India) were placed by the same operator (NV) at the junction of the attached gingiva and the movable mucosa, in the region between the second premolar and the first molar in the maxillary arch. An IOPA was taken to confirm the position of the mini-implants to assure stability.

Preparation of I-PRF and Intervention 

5-10 ml of venous blood of the patient was collected.The collected blood was then subjected to the double centrifuge technique proposed by Marx et al and Rashid et al (Rashid et al., 2017)(Marx and Garg, 2005; Rashid et al., 2017). 0.2ml of iPRF was injected intraligamentary in the disto-buccal, middle and disto- palatal points of the Maxillary Canine.  Immediately post I-PRF injection, the same volume of saline was injected in the control side.

Preparation of Vitamin D

Vitamin D3 (1,25-dihydroxyvitamine D3, the active form of vitamin D3) sachets(Calcitriol, Mibe, Germany) were used to prepare a diluted dose (50 pg) for local injections. Dimethylsulfoxide (0.2 ml) (DMSO, Bisolve B.V., Netherlands) was used for dilution and worked as a vehicle). 0.2ml of the solution was injected intraligamentary in the disto-buccal, middle and disto- palatal surface of the Maxillary Canine, while the contralateral canine received an intraligamentary administration of saline only as a control. 


Application of Force and Records Taken

Post-intervention, Canine retraction was initiated using elastomeric e-chains with 150 grams of force on each side from each Canine to the mini-implant. A Lateral Cephalogram was taken and day 0 of the intervention, and subsequently after 90 days of the start of the study. Intra Oral scan was taken using Runye Intraoral Scanner on day 0 of the intervention, and subsequently after 30 days, 60 days, and 90 days.

The scans were superimposed on each other using 3Shape Ortho Analyser software. Superimposition of the T0 scan and the following scans were done to rule out mesial movement(loss of anchorage) of the second premolar. Points were marked from the distal-most point on the canine and mesial-most point of the second premolar. The rate of canine distalization was calculated from the difference in this measurement between the scans at different periods. Degree of rotation was compared using a line drawn from the mesial and distal surface and compared to a line passing through the mid-palatal raphe. 


Pain Perception 

The pain perception of the patients was evaluated on each side: control and intervention at the time of intervention,  after 24 hours of the intervention and after 1 week, using a Visual Analog Scale (VAS).The patients were advised to not use any analgesics during this period.




 
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