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| Name | Class |
|---|---|
| Cheikh Anta Diop University, Senegal | OTHER |
| University of Ouagadougou, Burkina Faso | OTHER |
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Pre-eclampsia (PE) remains a major source of maternal and perinatal morbidity and mortality especially in low- and middle-income settings. PE, a pregnancy-specific hypertensive disorder, characterized by the development of placental endothelial dysfunction resulting in, among the most common diagnostic features, concomitant hypertension and proteinuria that may evolve into organs with fluctuating clinical specificities. Current studies indicate that 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, modulate of the dysbiotic oral microbiome. The purpose of the present study is to compare the PE outcomes in high-risk pregnant women receiving oral prophylactic measures to a control group. One specific question is addressed as follows according to the PICO principles: In high-risk pregnant women (Population), does oral prophylactic measures (Intervention) have a beneficial effect on PE parameters (Outcome) compared to pregnant women without any specific oral prophylactic measures (Control)?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | The control group will continue its usual oral hygiene practice. | |
| Oral prophylactic intervention | Experimental | For the study group, the oral prophylactic intervention will consist of provision of specfic package including soft-bristled manual toothbrush, toothpaste, and a kit of calibrated interdental brushes (IDBs)(Curaprox CPS; Curaden) of sizes corresponding to the diameter of their interdental spaces. The participants will be instructed to brush their teeeth twice-daily and to realise a daily interdental brushing until delivery. The instructions for the use of the toothbrush and IDBs comprised verbal instructions supported by practical demonstration. The first use of the material will be conducted under the supervision of a qualified public health professor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral prophylactic intervention | Other | The oral prophylactic intervention will consist of the provision of specific package including a soft-bristled manual toothbrush, toothpaste, and a kit of calibrated interdental brushes (IDBs)(Curaprox CPS; Curaden) of sizes corresponding to the diameter of their interdental spaces. The participants will be instructed to brush their teeeth twice-daily and to realise a daily interdental brushing until delivery. The instructions for the use of the toothbrush and IDBs comprised verbal instructions supported by practical demonstration. The first use of the material will be conducted under the supervision of a qualified public health professor. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of pre-eclampsia from baseline during the pregnancy | To determine if pregnant women suffer from pre-eclampsia, several indices are measured (diastolic or systolic pressure and proteinuria or urinary protein/creatinine ratio). The combination of the results of pressure and proteinuria permits to classify of a woman as suffering from pre-eclampsia if:
| 9 months of pregnancy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of pathogenic bacteria in the interdental microbiota during the pregnancy | Quantitative PCR experiments will be performed and a quantitative analysis of the interdental microbiota will be made | 3, 4, 6 and 8 months of pregnancy |
| Change of bleeding on probing during the pregnancy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Florence Carrouel, Dr | P2S, UR4129, University of Lyon | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital | Dakar | Senegal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34281133 | Background | Gare J, Kanoute A, Meda N, Viennot S, Bourgeois D, Carrouel F. Periodontal Conditions and Pathogens Associated with Pre-Eclampsia: A Scoping Review. Int J Environ Res Public Health. 2021 Jul 5;18(13):7194. doi: 10.3390/ijerph18137194. | |
| 41558746 | Derived | Carrouel F, Kanoute A, Faye D, Mazur M, Perrier H, Vitiello F, Ardan R, Clement C, Lan R, Bourgeois D. Impact of Interdental Brushing on Pregnancy-Associated Gingivitis: A Secondary Analysis of a Randomised Controlled Trial. J Clin Periodontol. 2026 Apr;53(4):539-549. doi: 10.1111/jcpe.70085. Epub 2026 Jan 20. |
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| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D011225 | Pre-Eclampsia |
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D046110 | Hypertension, Pregnancy-Induced |
| D009059 | Mouth Diseases |
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This trial is designed as an two-arm parallel cluster randomized controlled trial with antenatal obstetric clinic as the unit of randomisation and an allocation ratio of 1:1
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|
Quantification of the bleeding on probing of the teeth with a periodontal probe |
| 3, 4, 6 and 8 months of pregnancy |
| Change of pocket probing depth of teeth during the pregnancy | Quantification of the pocket probing depth of the teeth with a periodontal probe | 3, 4, 6 and 8 months of pregnancy |
| Change of clinical attachment level of teeth during the pregnancy | Quantification of the clinical attachment level of the teeth with a periodontal probe | 3, 4, 6 and 8 months of pregnancy |
| Change of gingival index of teeth during the pregnancy | Quantification of the gingival index | 3, 4, 6 and 8 months of pregnancy |
| D009057 | Stomatognathic Diseases |