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CTRI Number  CTRI/2025/11/096846 [Registered on: 03/11/2025] Trial Registered Prospectively
Last Modified On: 03/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Comparing Saliva and Blood Tests to Check Vitamin D Deficiency in Children 
Scientific Title of Study   Salivary Vitamin D: A novel non-invasive diagnostic method to detect vitamin D deficiency in children 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Karteek Eswara 
Designation  Professor 
Affiliation  Vinayaka Missions Sankarachariyar Dental College 
Address  Room no-6, Department of Pediatric and preventive dentistry, Vinayaka missions sankarachariyar dental college, NH-47, Sankari main road, Ariyanoor, Salem

Salem
TAMIL NADU
636308
India 
Phone  7013428237  
Fax    
Email  drkarteekeswara@vmsdc.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Karteek Eswara 
Designation  Professor 
Affiliation  Vinayaka Missions Sankarachariyar Dental College 
Address  Room no-6, Department of Pediatric and preventive dentistry, Vinayaka missions sankarachariyar dental college, NH-47, Sankari main road, Ariyanoor, Salem

Salem
TAMIL NADU
636308
India 
Phone  7013428237  
Fax    
Email  drkarteekeswara@vmsdc.edu.in  
 
Details of Contact Person
Public Query
 
Name  Karteek Eswara 
Designation  Professor 
Affiliation  Vinayaka Missions Sankarachariyar Dental College 
Address  Room no-6, Department of Pediatric and preventive dentistry, Vinayaka missions sankarachariyar dental college, NH-47, Sankari main road, Ariyanoor, Salem

Salem
TAMIL NADU
636308
India 
Phone  7013428237  
Fax    
Email  drkarteekeswara@vmsdc.edu.in  
 
Source of Monetary or Material Support  
SEED Money Project by VINAYAKA MISSIONS RESEARCH FOUNDATION (DEEMED TO BE UNIVERSITY) 
 
Primary Sponsor  
Name  Dr Karteek Eswara 
Address  NH-47 Sankari main road, Ariyanoor, Salem - 636308 
Type of Sponsor  Other [Vinayaka Missions Sankarachariyar Dental College] 
 
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 Karteek Eswara  Vinayaka Missions Sankarachariyar Dental College   Room no-6, Department of Pediatric and preventive dentistry, Vinayaka missions sankarachariyar dental college, NH-47, Sankari main road, Ariyanoor, Salem
Salem
TAMIL NADU 
7013428237

drkarteekeswara@vmsdc.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee of VMS Dental College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  Children aged 1-6 years
Children with ECC
Children without systemic conditions
Parent willing to participate
 
 
ExclusionCriteria 
Details  Children with systemic conditions
Children with metabolic conditions
Children taking vitamin D supplements
Parent not willing to participate.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Correlation between salivary and serum Vitamin D levels estimated using the ELISA method in children.   Baseline paired samples (08:00–10:00 AM) 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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)   14/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  14/11/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Applicable 
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  

Introduction

Vitamin D plays an essential role in the formation of healthy teeth, protection against dental caries. Vitamin D is an essential element in the diet. Vitamin D has an essential role in calcium and phosphate homeostasis. It regulates plasma ionized calcium and phosphorous levels by acting on intestinal absorption, renal excretion, and mobilization from bone. There is an increase in the prevalence of Vitamin D deficiency globally, mostly in the Middle East, China, Mongolia, and India. The conventional method detecting vitamin D deficiency is an invasive and painful procedure especially in children as it involves drawing of venous blood. Saliva sampling for the determination of vitamin D status could be more acceptable for infants and children, being painless, and could be done rapidly at remote sites or in the community. Assays for measurement of vitamin D concentration in saliva were first published over 30 years ago; however, these have not been commonly used in cohort or clinical studies for measurement of vitamin D status. While an assay that accurately measures vitamin D3 levels in saliva seems possible, a carefully defined protocol for sample collection may be needed to obtain replicable results that are highly correlated with vitamin D3 levels measured in serum. Many hormones, vitamins and immunoglobulins are expressed in saliva. Many biological substances expressed in saliva are used as biomarkers for detection of various diseases.

Aim 

To evaluate and co-relate the salivary and serum vitamin d levels in children undergoing dental rehabilitation under General anesthesia.

Objectives

To estimate the levels of  Vitamin D, in saliva using ELISA method / calorimetric method. To estimate the levels of Vitamin D in serum via the ELISA method. To compare  and co-relate the levels of Vitamin D in serum and saliva. To estimate the levels of Vitamin D associated with the severity of Early childhood caries.

Material and methodology

Study design Clinical Comparative study

Sample size 50 Children 25 per group.    

Source of study Children coming to the Department of Pediatric and Preventive Dentistry VMSDC Salem

Duration 24  months after ethical committee clearance 

Study population

A total of 50 children between 1 to 6 years will be included in this study.  Children who have to undergo full mouth rehabilitation for dental caries under general anesthesia will be included in the study. An informed consent from the parent visiting the Department of Paediatric and Preventive Dentistry, VMSDC Salem will be obtained.

Methodology

The children undergoing procedures under general anesthesia are NPO before the procedure. They are subjected to routine blood investigations as well. Blood that is drawn for the routine blood investigations will be used to evaluate the serum vitamin D levels. Prior to the collection of saliva, subjects will be asked to rinse their mouth with water and then wait for 1to 2 min for water clearance. Unstimulated whole saliva will be collected by making the subjects sit in an upright position with their heads slightly inclined. The passively drooled saliva collected in the floor of mouth will be expectorated into graduated saliva-collecting vials. Three millilitres of unstimulated whole saliva will be collected. The salivary samples will be stored in a deep freezer either immediately of after 2 to 3 hrs under further evaluation. The vitamin d levels in serum and saliva will be estimated using separate ELISA kits or calorimetric method . 

 
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