| 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
|
|
|
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
|
|
|
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 . |