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妊娠期牙周治疗预防不良妊娠结局(PROBE)干预研究——一项对照干预研究:方案论文。

The prevention of adverse pregnancy outcomes by periodontal treatment during pregnancy (PROBE) intervention study-A controlled intervention study: Protocol paper.

机构信息

The Research Unit for Dietary Studies, The Parker Institute, Copenhagen University Hospital, Copenhagen, Denmark.

Steno Diabetes Center Sjælland, Herlev, Denmark.

出版信息

PLoS One. 2024 May 13;19(5):e0302010. doi: 10.1371/journal.pone.0302010. eCollection 2024.

DOI:10.1371/journal.pone.0302010
PMID:38739615
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11090325/
Abstract

INTRODUCTION

Pregnancy increases the risk of periodontitis due to the increase in progesterone and estrogen. Moreover, periodontitis during pregnancy is associated with development of pregnancy and birth related complications. The aim of this study is to determine, whether periodontal treatment during pregnancy can reduce systemic inflammation and lower the risk of adverse pregnancy and birth related outcomes.

METHODS AND ANALYSIS

The PROBE study is a non-randomized controlled intervention study conducted among 600 pregnant women with periodontitis. The women will be recruited among all pregnant women at two Danish hospitals in Region Zealand during their nuchal translucency scan and will subsequently be screened for periodontitis. The intervention group includes 300 pregnant women, who will be offered state-of-the-art periodontal treatment during pregnancy. The control group includes additional 300 pregnant women, who will be offered periodontal treatment after giving birth. Outcome measures include periodontal measures, inflammatory, hormonal and glycaemic markers as well as the prevalence of preterm birth risk, low birth weight and risk markers of gestational diabetes mellitus (GDM) and preeclampsia that will be collected from all screened women and further during pregnancy week 20 and pregnancy week 35 for women enrolled in the intervention.

ETHICS AND DISSEMINATION

The study's findings will be published in peer reviewed journals and disseminated at national and international conferences and through social media. The PROBE study is designed to provide important new knowledge as to whether periodontal treatment during pregnancy can reduce the prevalence of complications related to pregnancy and birth.

CLINICAL TRIALS REGISTRATION

The study was registered on clinicaltrials.gov (NCT06110143).

摘要

简介

怀孕会导致孕激素和雌激素增加,从而增加牙周炎的风险。此外,怀孕期间的牙周炎与妊娠和分娩相关并发症的发展有关。本研究旨在确定怀孕期间的牙周治疗是否可以减轻全身炎症并降低不良妊娠和分娩相关结局的风险。

方法和分析

PROBE 研究是一项非随机对照干预研究,纳入了 600 名患有牙周炎的孕妇。这些妇女将在丹麦 Region Zealand 的两家医院进行颈部透明带扫描时被招募,并随后接受牙周炎筛查。干预组包括 300 名孕妇,她们将在怀孕期间接受最先进的牙周治疗。对照组包括另外 300 名孕妇,她们将在分娩后接受牙周治疗。主要观察指标包括牙周措施、炎症、激素和血糖标志物,以及早产风险、低出生体重和妊娠期糖尿病 (GDM) 和子痫前期的风险标志物的发生率,这些都将从所有筛查妇女中收集,并在干预组中招募的妇女妊娠第 20 周和第 35 周进一步收集。

伦理和传播

该研究的结果将发表在同行评议的期刊上,并在国家和国际会议上以及通过社交媒体进行传播。PROBE 研究旨在提供有关怀孕期间牙周治疗是否可以降低与妊娠和分娩相关并发症发生率的重要新信息。

临床试验注册

该研究已在 clinicaltrials.gov(NCT06110143)上注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d46b/11090325/70e350048708/pone.0302010.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d46b/11090325/70e350048708/pone.0302010.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d46b/11090325/70e350048708/pone.0302010.g001.jpg

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本文引用的文献

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Periodontal disease and systemic health: An update for medical practitioners.牙周病与全身健康:医学从业者的最新知识更新。
Ann Acad Med Singap. 2022 Sep;51(9):567-574. doi: 10.47102/annals-acadmedsg.2021503.
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Front Med (Lausanne). 2022 Aug 30;9:984291. doi: 10.3389/fmed.2022.984291. eCollection 2022.
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Association between Maternal Periodontitis and Development of Systematic Diseases in Offspring.
母亲牙周炎与子代系统性疾病发生的相关性。
Int J Mol Sci. 2022 Feb 24;23(5):2473. doi: 10.3390/ijms23052473.
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Periodontitis and Gestational Diabetes Mellitus: A Potential Inflammatory Vicious Cycle.牙周炎与妊娠糖尿病:潜在的炎症恶性循环。
Int J Mol Sci. 2021 Oct 31;22(21):11831. doi: 10.3390/ijms222111831.
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Periodontal care attendance in Denmark in 2012-2016 - a nationwide register-based study.2012 - 2016年丹麦的牙周护理就诊情况——一项基于全国登记数据的研究
Acta Odontol Scand. 2022 May;80(4):264-272. doi: 10.1080/00016357.2021.1998611. Epub 2021 Nov 9.
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Association between obesity and chronic periodontitis: A nationwide population-based cohort study in Taiwan.肥胖与慢性牙周炎的相关性:台湾一项基于全国人口的队列研究。
Medicine (Baltimore). 2021 Oct 15;100(41):e27506. doi: 10.1097/MD.0000000000027506.
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