| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [navaneethan@saveetha.com].
- 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.
- 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 â—Adults between 18 years and 35 years â— No systemic illness, or absence of bone metabolic disorders. â— Periodontally healthy subjects. â— Good oral hygiene.
Exclusion Criteria â— Patients unwilling to participate in the study. â— Patients with a history of anemia, blood loss, or vascular diseases. â— Patients with a history of smoking
â— 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.
|