Kanoute Aida, Gare Jocelyne, Meda Nicolas, Viennot Stephane, Tramini Paul, Fraticelli Laurie, Carrouel Florence, Bourgeois Denis
Public Health Service, Department of Dentistry, Cheikh Anta Diop University, Dakar 10700, Senegal.
Health, Systemic, Process, UR 4129 Research Unit, University Claude Bernard Lyon 1, University of Lyon, 69008 Lyon, France.
Methods Protoc. 2021 Sep 5;4(3):61. doi: 10.3390/mps4030061.
Pre-eclampsia (PE), a pregnancy-specific hypertensive disorder, characterized by the development of placental endothelial dysfunction, remains a major source of maternal and perinatal morbidity and mortality, especially in low- and middle-income settings. Periodontal disorders during pregnancy, and particularly periodontal pathogens, may be related to the risk of PE. Standard oral hygiene methods, based mainly on the joint use of toothbrushes and interdental brushes, reduce periodontal inflammatory risk and modulate the dysbiosis of the oral microbiome. The aim of this trial is to compare the PE outcomes in high-risk pregnant women receiving oral prophylactic measures to a control group. This trial is designed as a two-arm, parallel, cluster randomized controlled trial with the antenatal obstetric clinic as the unit of randomization and an allocation ratio of 1:1. The pregnant women will be included at 3 months of pregnancy and will be followed throughout the pregnancy. The primary outcome measure will be the incidence of PE from a baseline during the pregnancy. Secondary outcomes measures will include changes from the baseline in quantification of the pathogenic bacterial load of the interdental microbiota, the severity scores of periodontal indicators, and the incidence of adverse perinatal outcomes. This trial should demonstrate that the implementation of daily oral hygiene reduces oral dysbiosis, the incidence of periodontal disease, and the risk of PE.
子痫前期（PE）是一种特定于妊娠的高血压疾病，其特征为胎盘内皮功能障碍的发展，仍然是孕产妇和围产期发病和死亡的主要原因，尤其是在低收入和中等收入地区。孕期的牙周疾病，特别是牙周病原体，可能与子痫前期的风险有关。主要基于联合使用牙刷和牙间隙刷的标准口腔卫生方法，可降低牙周炎症风险并调节口腔微生物群的生态失调。本试验的目的是比较接受口腔预防措施的高危孕妇与对照组的子痫前期结局。本试验设计为双臂、平行、整群随机对照试验，以产前产科诊所作为随机单位，分配比例为1:1。孕妇将在妊娠3个月时纳入，并在整个孕期进行随访。主要结局指标将是妊娠期间从基线开始的子痫前期发病率。次要结局指标将包括牙间隙微生物群致病细菌载量定量、牙周指标严重程度评分以及不良围产期结局发生率相对于基线的变化。本试验应证明实施日常口腔卫生可减少口腔生态失调、牙周疾病的发生率以及子痫前期的风险。
