{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T00:32:25Z","timestamp":1790728345983,"version":"4.1.0"},"reference-count":36,"publisher":"MDPI AG","issue":"3","license":[{"start":{"date-parts":[[2021,9,5]],"date-time":"2021-09-05T00:00:00Z","timestamp":1630800000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["MPs"],"abstract":"<jats:p>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.<\/jats:p>","DOI":"10.3390\/mps4030061","type":"journal-article","created":{"date-parts":[[2021,9,6]],"date-time":"2021-09-06T23:55:22Z","timestamp":1630972522000},"page":"61","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Effect of Oral Prophylactic Measures on the Occurrence of Pre-Eclampsia (OP-PE) in High-Risk Pregnant Women: A Cluster Randomized Controlled Trial"],"prefix":"10.3390","volume":"4","author":[{"given":"Aida","family":"Kanoute","sequence":"first","affiliation":[{"name":"Public Health Service, Department of Dentistry, Cheikh Anta Diop University, Dakar 10700, Senegal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jocelyne","family":"Gare","sequence":"additional","affiliation":[{"name":"Health, Systemic, Process, UR 4129 Research Unit, University Claude Bernard Lyon 1, University of Lyon, 69008 Lyon, France"},{"name":"Public Health Laboratory (LASAP), ED2S Doctoral School of Sciences and Health, University Joseph Ki Zerbo, Ouagadougou 7021, Burkina Faso"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicolas","family":"Meda","sequence":"additional","affiliation":[{"name":"Public Health Laboratory (LASAP), ED2S Doctoral School of Sciences and Health, University Joseph Ki Zerbo, Ouagadougou 7021, Burkina Faso"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephane","family":"Viennot","sequence":"additional","affiliation":[{"name":"Health, Systemic, Process, UR 4129 Research Unit, University Claude Bernard Lyon 1, University of Lyon, 69008 Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Tramini","sequence":"additional","affiliation":[{"name":"Department of Public Health, Faculty of Dental Medicine, University of Montpellier, 34090 Montpellier, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2647-658X","authenticated-orcid":false,"given":"Laurie","family":"Fraticelli","sequence":"additional","affiliation":[{"name":"Health, Systemic, Process, UR 4129 Research Unit, University Claude Bernard Lyon 1, University of Lyon, 69008 Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6823-1636","authenticated-orcid":false,"given":"Florence","family":"Carrouel","sequence":"additional","affiliation":[{"name":"Health, Systemic, Process, UR 4129 Research Unit, University Claude Bernard Lyon 1, University of Lyon, 69008 Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4754-2512","authenticated-orcid":false,"given":"Denis","family":"Bourgeois","sequence":"additional","affiliation":[{"name":"Health, Systemic, Process, UR 4129 Research Unit, University Claude Bernard Lyon 1, University of Lyon, 69008 Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2021,9,5]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"481095","DOI":"10.1155\/2011\/481095","article-title":"Public Health Perspectives of Preeclampsia in Developing Countries: Implication for Health System Strengthening","volume":"2011","author":"Osungbade","year":"2011","journal-title":"J. Pregnancy"},{"key":"ref_2","doi-asserted-by":"crossref","unstructured":"Bilano, V.L., Ota, E., Ganchimeg, T., Mori, R., and Souza, J.P. (2014). Risk Factors of Pre-Eclampsia\/Eclampsia and Its Adverse Outcomes in Low- and Middle-Income Countries: A WHO Secondary Analysis. PLoS ONE, 9.","DOI":"10.1371\/journal.pone.0091198"},{"key":"ref_3","doi-asserted-by":"crossref","unstructured":"Al Khalaf, S.Y., O\u2019Reilly, \u00c9.J., McCarthy, F.P., Kublickas, M., Kublickiene, K., and Khashan, A.S. (2021). Pregnancy Outcomes in Women with Chronic Kidney Disease and Chronic Hypertension: A National Cohort Study. Am. J. Obs. Gynecol.","DOI":"10.1136\/jech-2020-SSMabstracts.69"},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"213","DOI":"10.1038\/hr.2016.126","article-title":"Epidemiology of Hypertensive Disorders in Pregnancy: Prevalence, Risk Factors, Predictors and Prognosis","volume":"40","author":"Umesawa","year":"2017","journal-title":"Hypertens. Res."},{"key":"ref_5","first-page":"e202105","article-title":"Cardiovascular Adverse Events in Pregnancy: A Global Perspective","volume":"2021","author":"Kotit","year":"2021","journal-title":"Glob. Cardiol. Sci. Pract."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"544.e1","DOI":"10.1016\/j.ajog.2013.08.019","article-title":"Incidence of Preeclampsia: Risk Factors and Outcomes Associated with Early- versus Late-Onset Disease","volume":"209","author":"Lisonkova","year":"2013","journal-title":"Am. J. Obstet. Gynecol."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"631","DOI":"10.1016\/S0140-6736(10)60279-6","article-title":"Pre-Eclampsia","volume":"376","author":"Steegers","year":"2010","journal-title":"Lancet"},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"413","DOI":"10.3389\/fcimb.2020.00413","article-title":"Placental Microbial Colonization and Its Association with Pre-Eclampsia","volume":"10","author":"Olaniyi","year":"2020","journal-title":"Front. Cell Infect. Microbiol."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"23905","DOI":"10.3390\/ijms161023905","article-title":"Cardiovascular Complications of Pregnancy","volume":"16","author":"Gongora","year":"2015","journal-title":"Int. J. Mol. Sci."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"59","DOI":"10.3389\/fcvm.2020.00059","article-title":"Hypertensive Disorders of Pregnancy and Future Cardiovascular Health","volume":"7","author":"Melchiorre","year":"2020","journal-title":"Front. Cardiovasc. Med."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"33","DOI":"10.15644\/asc51\/1\/4","article-title":"The Association between Periodontal Disease and Preterm Low Birthweight in Kosovo","volume":"51","author":"Meqa","year":"2017","journal-title":"Acta Stomatol. Croat."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"139","DOI":"10.3389\/fimmu.2017.00139","article-title":"Role of Maternal Periodontitis in Preterm Birth","volume":"8","author":"Ren","year":"2017","journal-title":"Front. Immunol."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"115","DOI":"10.3109\/14767058.2014.987751","article-title":"Association between Maternal Periodontitis and Preterm and\/or Low Birth Weight Infants in Normal Pregnancies","volume":"29","author":"Usin","year":"2016","journal-title":"J. Matern. Fetal Neonatal Med."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"S219","DOI":"10.1111\/jcpe.12951","article-title":"Periodontal Manifestations of Systemic Diseases and Developmental and Acquired Conditions: Consensus Report of Workgroup 3 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions","volume":"45","author":"Jepsen","year":"2018","journal-title":"J. Clin. Periodontol."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"383","DOI":"10.1016\/j.ajog.2019.04.029","article-title":"Placental Colonization with Periodontal Pathogens: The Potential Missing Link","volume":"221","author":"Fischer","year":"2019","journal-title":"Am. J. Obstet. Gynecol."},{"key":"ref_16","doi-asserted-by":"crossref","unstructured":"Terzic, M., Aimagambetova, G., Terzic, S., Radunovic, M., Bapayeva, G., and Lagan\u00e0, A.S. (2021). Periodontal Pathogens and Preterm Birth: Current Knowledge and Further Interventions. Pathogens, 10.","DOI":"10.3390\/pathogens10060730"},{"key":"ref_17","doi-asserted-by":"crossref","unstructured":"Hajishengallis, G., and Chavakis, T. (2021). Local and Systemic Mechanisms Linking Periodontal Disease and Inflammatory Comorbidities. Nat. Rev. Immunol., 1\u201315.","DOI":"10.1038\/s41577-020-00488-6"},{"key":"ref_18","doi-asserted-by":"crossref","unstructured":"Gare, J., Kanoute, A., Meda, N., Viennot, S., Bourgeois, D., and Carrouel, F. (2021). Periodontal Conditions and Pathogens Associated with Pre-Eclampsia: A Scoping Review. Int. J. Environ. Res. Public Health, 18.","DOI":"10.3390\/ijerph18137194"},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"579766","DOI":"10.3389\/fcimb.2021.579766","article-title":"Preterm Birth Is Correlated with Increased Oral Originated Microbiome in the Gut","volume":"11","author":"Yin","year":"2021","journal-title":"Front. Cell Infect. Microbiol."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"1335","DOI":"10.1016\/j.csbj.2021.02.010","article-title":"The Oralome and Its Dysbiosis: New Insights into Oral Microbiome-Host Interactions","volume":"19","author":"Radaic","year":"2021","journal-title":"Comput. Struct. Biotechnol. J."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"15127","DOI":"10.1038\/s41598-019-51938-8","article-title":"Calibrated Interdental Brushing for the Prevention of Periodontal Pathogens Infection in Young Adults\u2014A Randomized Controlled Clinical Trial","volume":"9","author":"Bourgeois","year":"2019","journal-title":"Sci. Rep."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"566","DOI":"10.1111\/eos.12302","article-title":"Efficacy of Interdental Calibrated Brushes on Bleeding Reduction in Adults: A 3-Month Randomized Controlled Clinical Trial","volume":"124","author":"Bourgeois","year":"2016","journal-title":"Eur. J. Oral Sci."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"296","DOI":"10.1111\/idj.12548","article-title":"The Relationship between the Anti-Porphyromonas gingivalis Immunoglobulin G Subclass Antibody and Small for Gestational Age Delivery: A Longitudinal Study in Pregnant Japanese Women","volume":"70","author":"Ye","year":"2020","journal-title":"Int. Dent. J."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"1182","DOI":"10.1902\/jop.2014.130604","article-title":"Quantification of Periodontal Pathogens in Vascular, Blood, and Subgingival Samples from Patients with Peripheral Arterial Disease or Abdominal Aortic Aneurysms","volume":"85","author":"Figuero","year":"2014","journal-title":"J. Periodontol."},{"key":"ref_25","doi-asserted-by":"crossref","unstructured":"Bourgeois, D., Inquimbert, C., Ottolenghi, L., and Carrouel, F. (2019). Periodontal Pathogens as Risk Factors of Cardiovascular Diseases, Diabetes, Rheumatoid Arthritis, Cancer, and Chronic Obstructive Pulmonary Disease-Is There Cause for Consideration?. Microorganisms, 7.","DOI":"10.3390\/microorganisms7100424"},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"591626","DOI":"10.3389\/fmicb.2020.591626","article-title":"Porphyromonas Gingivalis Placental Atopobiosis and Inflammatory Responses in Women with Adverse Pregnancy Outcomes","volume":"11","author":"Castillo","year":"2020","journal-title":"Front. Microbiol."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"16","DOI":"10.1186\/s13643-016-0195-7","article-title":"Risk of Adverse Pregnancy Outcomes in Women with Periodontal Disease and the Effectiveness of Interventions in Decreasing This Risk: Protocol for Systematic Overview of Systematic Reviews","volume":"5","author":"Vanterpool","year":"2016","journal-title":"Syst. Rev."},{"key":"ref_28","doi-asserted-by":"crossref","unstructured":"Vanterpool, S.F., Been, J.V., Houben, M.L., Nikkels, P.G.J., De Krijger, R.R., Zimmermann, L.J.I., Kramer, B.W., Progulske-Fox, A., and Reyes, L. (2016). Porphyromonas Gingivalis within Placental Villous Mesenchyme and Umbilical Cord Stroma Is Associated with Adverse Pregnancy Outcome. PLoS ONE, 11.","DOI":"10.1371\/journal.pone.0146157"},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"e7586","DOI":"10.1136\/bmj.e7586","article-title":"SPIRIT 2013 Explanation and Elaboration: Guidance for Protocols of Clinical Trials","volume":"346","author":"Chan","year":"2013","journal-title":"BMJ"},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"611","DOI":"10.1902\/jop.2015.140520","article-title":"Update on Prevalence of Periodontitis in Adults in the United States: NHANES 2009 to 2012","volume":"86","author":"Eke","year":"2015","journal-title":"J. Periodontol."},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"1045","DOI":"10.1177\/0022034514552491","article-title":"Global Burden of Severe Periodontitis in 1990-2010: A Systematic Review and Meta-Regression","volume":"93","author":"Kassebaum","year":"2014","journal-title":"J. Dent. Res."},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"431","DOI":"10.2174\/1874210601509010431","article-title":"A Colorimetric Interdental Probe as a Standard Method to Evaluate Interdental Efficiency of Interdental Brush","volume":"9","author":"Bourgeois","year":"2015","journal-title":"Open Dent. J."},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"299","DOI":"10.1111\/idj.12300","article-title":"The Bleeding on Brushing Index: A Novel Index in Preventive Dentistry","volume":"67","author":"Rosenauer","year":"2017","journal-title":"Int. Dent. J."},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"S173","DOI":"10.1002\/JPER.17-0721","article-title":"Periodontitis: Consensus Report of Workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions","volume":"89","author":"Papapanou","year":"2018","journal-title":"J. Periodontol."},{"key":"ref_35","doi-asserted-by":"crossref","first-page":"2169","DOI":"10.1002\/sim.5352","article-title":"A Simple Sample Size Formula for Analysis of Covariance in Cluster Randomized Trials","volume":"31","author":"Teerenstra","year":"2012","journal-title":"Stat. Med."},{"key":"ref_36","doi-asserted-by":"crossref","unstructured":"Ma, J., Akhtar-Danesh, N., Dolovich, L., and Thabane, L. (2011). The CHAT investigators Imputation Strategies for Missing Binary Outcomes in Cluster Randomized Trials. BMC Med. Res. 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