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CTRI Number  CTRI/2024/08/072307 [Registered on: 12/08/2024] Trial Registered Prospectively
Last Modified On: 06/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Single Arm Study 
Public Title of Study   Impact Of Vitamin D Supplementation On Teeth Stability Post Orthodontic Treatment In People With Low Vitamin D Levels 
Scientific Title of Study   Effect of Oral Vitamin D Supplementation on Post Orthodontic Relapse in Vitamin D Insufficient Individuals - A Quasi Experimental 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  Dr Anna Thomas P 
Designation  Post Graduate Student 
Affiliation  Indira Gandhi Institute of Dental Sciences, Pondicherry 
Address  Department Of Orthodontics, Indira Gandhi Institute of Dental Sciences, Sri Balaji Vidyapeeth campus, Pillaiyarkuppam, Pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  09526526140  
Fax    
Email  annapuliyelil@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pavithranand A 
Designation  Professor and Head of Deprtment 
Affiliation  Indira Gandhi Institute of Dental Sciences, Pondicherry 
Address  Department Of Orthodontics, Indira Gandhi Institute of Dental Sciences, Sri Balaji Vidyapeeth campus, Pillaiyarkuppam, Pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9443183590  
Fax    
Email  pavithranandammayappan@igids.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Pavithranand A 
Designation  Professor and Head of Deprtment 
Affiliation  Indira Gandhi Institute of Dental Sciences, Pondicherry 
Address  Department Of Orthodontics, Indira Gandhi Institute of Dental Sciences, Sri Balaji Vidyapeeth campus, Pillaiyarkuppam, Pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9443183590  
Fax    
Email  pavithranandammayappan@igids.ac.in  
 
Source of Monetary or Material Support  
Indira Gandhi Institute of Dental Sciences, Sri Balaji Vidyapeeth, Pillaiyarkuppam, Pondicherry,India,607402 
 
Primary Sponsor  
Name  Dr Anna Thomas P 
Address  Department of Orthodontics, Indira Gandhi Institute of Dental Sciences, Sri Balaji Vidyapeeth, Pillaiyarkuppam, Pondicherry 
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 Anna Thomas P  Indira Gandhi Institute of Dental Sciences  Department of Orthodontics Pillaiyarkuppam Pondicherry
Pondicherry
PONDICHERRY 		 9526526140

annapuliyelil@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Indira Gandhi Institute of Dental Sciences   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M264||Malocclusion, unspecified, (2) ICD-10 Condition: E559||Vitamin D deficiency, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cap.Vitamin D  60000 IU oral per week for 2 months 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1 Patients in settling phase of fixed orthodontic therapy.
2 Patient with insufficient Vit D levels between 50-70 nmol/L(20-30 ng/ml)
3 Patients with deficient Vit D levels of less than 50nmol/L (less than 20 ng/ml)
4 Patients who provide oral and written consent to participation  
 
ExclusionCriteria 
Details  1. Patients with history of midline diastema.
2. Patients with history of oral habits
3. Any craniofacial/developmental anomalies.
4. Congenitally missing/impacted teeth/ hypodontia excluding absent third molars.
5. Patients with debilitating diseases and bone metabolic disorders.
6. Patients on corticosteroids and anticonvulsants.
7. Patients already on Vitamin D supplements
8. Patients with very poor oral hygiene, with active periodontal diseases.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Evaluation of post orthodontic relapse in Vitamin D insufficient patients post oral Vitamin D supplementation  Outcome will be assessed 3 months post orthodontic treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Compliance and tolerability to Vit D supplement  2 months 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
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)   02/09/2024 
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   The study aims to provide insights into whether vitamin D supplementation can help reduce post-orthodontic relapse in patients with vitamin D insufficiency, potentially offering a new approach to improve orthodontic treatment outcomes. The study targets patients in the settling phase of their orthodontic treatment and have been identified as having insufficient Vitamin D levels. The patients with deficient Vitamin D levels  will be given vitamin D supplements and then monitored for three months after their treatment is completed during the retention phase. Littles Irregularity Index will be used to measure the relapse. By comparing the tooth positions immediately after treatment and again three months later, we can determine if the vitamin D supplementation has any effect on reducing relapse - the tendency of teeth to move back towards their original positions after orthodontic treatment. 
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