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

• Published in: PloS one 2024-05, Vol.19 (5), p.e0302010-e0302010
• Main Authors: Winckler, Karoline, Bukkehave, Kathrine Hansen, Tarnow, Lise, Iversen, Peter Bindslev, Damgaard, Christian, Ditlev, Sisse Bolm, Kofoed-Enevoldsen, Allan, Fischer, Heidi Marianne, Dueholm, Signe Camilla Hjuler, Lauenborg, Jeannet, Trier, Cæcilie, Heitmann, Berit Lilienthal
• Format: Article
• Language: English
• Subjects: Adult; Biology and Life Sciences; Birth weight; Cardiovascular disease; Childbirth & labor; Chronic illnesses; Clinical trials; Dental care; Dental insurance; Dentists; Diabetes; Diabetes mellitus; Diabetes, Gestational; Estrogen; Estrogens; Ethylenediaminetetraacetic acid; Female; Gestational diabetes; Gum disease; Health risks; Health services; Hospitals; Humans; Infant, Low Birth Weight; Infant, Newborn; Inflammation; Intervention; Low birth weight; Medicine and Health Sciences; Oral hygiene; Out of pocket costs; People and Places; Periodontitis; Periodontitis - complications; Periodontitis - therapy; Pre-eclampsia; Pre-Eclampsia - prevention & control; Preeclampsia; Pregnancy; Pregnancy complications; Pregnancy Complications - prevention & control; Pregnancy Outcome; Pregnant women; Premature birth; Premature Birth - prevention & control; Progesterone; Questionnaires; Risk; Study Protocol; Womens health
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0302010

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