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临床试验/CTRI/2025/11/096846
CTRI/2025/11/096846Not Applicable不适用

Salivary Vitamin D: A novel non-invasive diagnostic method to detect vitamin D deficiency in children

Dr Karteek Eswara1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年11月14日最近更新:

试验速览

阶段
不适用
状态
Not Applicable
发起方
入组人数
48
试验地点
1
主要终点
Correlation between salivary and serum Vitamin D levels estimated using the ELISA method in children.

研究概览

简要总结

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 .

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
1.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • Children aged 1-6 years Children with ECC Children without systemic conditions Parent willing to participate.

排除标准

  • Children with systemic conditions Children with metabolic conditions Children taking vitamin D supplements Parent not willing to participate.

结局指标

主要结局

Correlation between salivary and serum Vitamin D levels estimated using the ELISA method in children.

时间窗: Baseline paired samples (08:00–10:00 AM)

次要结局

未报告次要终点

研究者

发起方
Dr Karteek Eswara
申办方类型
Other [Vinayaka Missions Sankarachariyar Dental College]
责任方
Principal Investigator
主要研究者

Karteek Eswara

Vinayaka Missions Sankarachariyar Dental College

研究点 (1)

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