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CARES-HAPIN 方案:一项关于环境烟草烟雾暴露与儿童早期龋病风险的双向队列研究。

Protocol for CARES-HAPIN: an ambidirectional cohort study on exposure to environmental tobacco smoke and risk of early childhood caries.

机构信息

Department of Environmental Health Engineering, Faculty of Public Health, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), Chennai, Tamil Nadu, India.

Department of Pediatric and Preventive Dentistry, Dr. D.Y. Patil Dental College and Hospital, Dr. D.Y. Patil Vidyapeeth, Pune, Maharashtra, India.

出版信息

BMJ Open. 2024 May 15;14(5):e083874. doi: 10.1136/bmjopen-2024-083874.

DOI:10.1136/bmjopen-2024-083874
PMID:38749682
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11097839/
Abstract

INTRODUCTION

Prenatal and postnatal exposure to environmental tobacco smoke (ETS) has been linked with early childhood caries (ECC), but the specific molecular mechanisms and pathways remain largely unknown. The Caries Risk from exposure to Environmental tobacco Smoke (CARES) within the Household Air Pollution Intervention Network (HAPIN) study aims to establish the association between ETS and ECC by employing epidemiological and novel biomarker-based approaches. Here, we outline the overall design and rationale of the project.

METHODS AND ANALYSIS

We will leverage the infrastructure and data from the HAPIN trial (India) to mount the CARES study. In this ambidirectional cohort study, children (n=735, aged: 3-5 years) will undergo ECC examination by a trained dentist using standard criteria and calibrated methods. Structured questionnaires will be used to gather information on sociodemographic variables, dietary habits, oral hygiene, oral health-related quality of life and current exposure to ETS. We will collect non-invasive or minimally invasive biospecimens (i.e., saliva, buccal cells, dried blood spots and urine) from a subset of HAPIN children (n=120) to assess a battery of biomarkers indicative of exposure to ETS, early biological effect and epigenetic modifications. Both self-reported and objective measures of ETS exposure collected longitudinally during in utero and early postnatal periods will be accessed from the HAPIN database. We will apply current science data techniques to assess the association and interrelationships between ETS, ECC, and multiple biomarkers.

ETHICS AND DISSEMINATION

Information gathered in this research will be published in peer-reviewed journals and summaries will be shared with the key stakeholders as well as patients and their parents/guardians involved in this study. Sri Ramachandra Institute of Higher Education and Research Ethics Board has approved the study protocol (IEC-NI22/JUL/83/82).

TRIAL REGISTRATION NUMBER

NCT02944682.

摘要

简介

产前和产后接触环境烟草烟雾(ETS)与儿童早期龋病(ECC)有关,但具体的分子机制和途径仍知之甚少。家庭空气污染干预网络(HAPIN)中的烟草烟雾暴露致龋风险(CARES)研究旨在通过采用流行病学和新型生物标志物方法来确定 ETS 与 ECC 之间的关联。本文概述了该项目的总体设计和原理。

方法和分析

我们将利用 HAPIN 试验(印度)的基础设施和数据来开展 CARES 研究。在这项双向队列研究中,将由经过培训的牙医使用标准标准和校准方法对儿童(n=735,年龄:3-5 岁)进行 ECC 检查。将使用结构化问卷收集社会人口统计学变量、饮食习惯、口腔卫生、口腔健康相关生活质量和当前接触 ETS 的信息。我们将从 HAPIN 儿童(n=120)中收集非侵入性或微创生物样本(即唾液、颊细胞、干血斑和尿液),以评估一系列表明接触 ETS、早期生物效应和表观遗传修饰的生物标志物。将从 HAPIN 数据库中获取纵向收集的自我报告和客观 ETS 暴露测量值,包括宫内和新生儿早期。我们将应用当前科学数据技术来评估 ETS、ECC 和多个生物标志物之间的关联和相互关系。

伦理和传播

本研究收集的信息将发表在同行评议的期刊上,并将与关键利益相关者以及参与该研究的患者及其父母/监护人分享摘要。斯里拉马钱德拉研究所高等教育和研究伦理委员会已批准该研究方案(IEC-NI22/JUL/83/82)。

试验注册编号

NCT02944682。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5f42/11097839/5a0b37730833/bmjopen-2024-083874f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5f42/11097839/1e44f1b480a5/bmjopen-2024-083874f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5f42/11097839/5a0b37730833/bmjopen-2024-083874f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5f42/11097839/1e44f1b480a5/bmjopen-2024-083874f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5f42/11097839/5a0b37730833/bmjopen-2024-083874f02.jpg

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