Oral Prophylactic Measures on the Occurrence of Pre-eclampsia (OP-PE)

NCT ID: NCT04989075

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-15
• Study Completion Date: 2023-07-25

Brief Summary

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)?

Conditions

Pregnancy Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Control group

The control group will continue its usual oral hygiene practice.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Oral prophylactic intervention

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.

Group Type: EXPERIMENTAL

Oral prophylactic intervention

Intervention Type: 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.

Interventions

Oral prophylactic intervention

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• pregnant woman
• women from sub-Saharan Africa
• aged from 18 to 40 years old
• nullipares at the time of the obstetrical consultation
• up to 12 weeks pregnant
• acceptance of the terms and conditions of the study
• signature of the informed consent form,

Exclusion Criteria

• fetal distress
• congenital uterine and vaginal abnormalities
• infectious or systemic diseases such as HIV, tuberculosis, candidiasis, cancers, hemopathies
• premature termination of pregnancy for medical reasons
• diagnosis of periodontitis defined as interproximal CAL ≥1 mm at ≥2 non-adjacent teeth, or buccal/oral CAL ≥3 mm with probing depth >3 mm at ≥2 teeth, not attributable to non-periodontitis-related causes
• history or treatment of PD
• a course of dental or orthodontic treatment
• absence of the 4 premolar-molar pairs
• less than 20 natural teeth, excluding third molars
• medication affecting the gum and/or oral mucosa
• regularly using interdental brushes and/or dental floss and/or mouthwash
• unable to answer questions or non-cooperative.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cheikh Anta Diop University, Senegal

OTHER

Sponsor Role: collaborator

University of Ouagadougou, Burkina Faso

OTHER

Sponsor Role: collaborator

Claude Bernard University

OTHER

Sponsor Role: lead

Responsible Party

Carrouel Florence

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Florence Carrouel, Dr

Role: STUDY_DIRECTOR

P2S, UR4129, University of Lyon

Locations

Hospital

Dakar, , Senegal

Countries

Senegal

References

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.

Reference Type: BACKGROUND

PMID: 34281133 (View on PubMed)

Other Identifiers

OP-PE

Identifier Type: -

Identifier Source: org_study_id