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临床试验/CTRI/2025/07/090765
CTRI/2025/07/090765尚未招募不适用

Identification of salivary and blood biomarkers for Early childhood caries diagnosis in mother and child

Rajiv Gandhi University of Health Sciences1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
84
试验地点
1
主要终点
Correlation of mother and child in association with ECC

研究概览

简要总结

ECC is a widespread dental condition that affects children under six years, causing pain and long-term oral health issues. While several factors contribute to ECC including diet, oral hygiene, and genetic predisposition maternal influence through biological markers remains underexplored. This study aims to identify and correlate potential salivary and blood biomarkers in mothers that can predict Early Childhood Caries (ECC) in their children.

 Methodology: The project adopts a case-control study design involving 84 participants (42 mother-child pairs with ECC and 42 without ECC). The study will analyse biomarkers such as salivary metabolites, Human Leukocyte Antigen (HLA)-DR and DQ, Vitamin D, and iron profiles in mother-child pairs with and without ECC. The saliva will be collected and stored in the frozen form for analysis. Nuclear Magnetic Resonance (NMR) spectroscopy will be used to analyse the salivary biomarkers and ELISA tests will be used to detect HLA antigens. Laboratory iron and Vitamin D profile will be made. Statistical analyses, including Spearman’s correlation and regression, will determine associations.

 The study seeks to develop a reliable panel of biomarkers for early detection and preventive strategies, ultimately benefiting public health by enabling timely intervention before caries onset

研究设计

研究类型
Observational

入排标准

年龄范围
24.00 Month(s) 至 71.00 Month(s)(—)
性别
All

入选标准

  • Patients in the age group of 24–71 months, Patients accompanied by their mother.

排除标准

  • medically compromised, history of congenital and genetic problems.

结局指标

主要结局

Correlation of mother and child in association with ECC

时间窗: 6 months, 18 months

次要结局

未报告次要终点

研究者

申办方类型
Other [university]
责任方
Principal Investigator
主要研究者

Dr Raghavendra Havale

AME Dental College, Raichur

研究点 (1)

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