Education-Based Oral Health Promotion Intervention During Pregnancy: Implementation Protocol in Bangladesh

Официальное название

Oral Health Promotion Intervention During Pregnancy: Bangladesh Perspective

Обзор

In Bangladesh, over 95% of pregnant women suffer from gum disease (gingivitis or periodontitis), yet oral health is rarely included in standard pregnancy check-ups. This study tests a new "Integrated Oral Health Promotion Package" to see if teaching oral hygiene during routine prenatal visits can improve the health of mothers. Pregnant women (ages 18-45) will be divided into two groups. The intervention group will receive two face-to-face education sessions with a dental assistant, learn a specific tooth-brushing technique, and receive weekly SMS text reminders to brush their teeth. The control group will receive the standard pregnancy care currently offered in Bangladesh. Researchers will track the participants for 12 weeks to see if the education and reminders lead to better brushing habits (twice-daily) and cleaner teeth and gums compared to the standard care group.

Подробное описание

Study Design and Ethical Oversight This cluster-randomized, hybrid effectiveness-implementation trial (Protocol Version 1.1, March 2026) utilizes the PRECEDE-PROCEED framework to address maternal oral health in Bangladesh. The study is conducted in eight Upazila Health Complexes (UHCs) across eight administrative divisions. This protocol and all recruitment materials have been approved by the IRB of Bangladesh Medical University. Any future amendments to the protocol or study sites will be submitted for board approval before implementation. To prevent treatment contamination, staff at intervention sites will not rotate to control sites, and clinical examiners remain blinded to the 1:1 cluster allocation throughout the 12-week follow-up.

Participant Enrollment and Power A total of 688 pregnant women (86 per cluster) with a gestational age ≤24 weeks will be recruited. The sample size provides 80% power at a 5% significance level to detect a 20% improvement in the primary outcome, assuming a 1.5 design effect (ICC = 0.05) and a 20% attrition rate.

Statistical Analysis Plan (SAP) and Assumption Verification Analysis follows the Intention-to-Treat (ITT) principle using Mixed-Effects Linear Regression for clinical scores (OHI-S) and Mixed-Effects Logistic Regression for binary behavioral outcomes. The UHC is included as a random effect to account for clustering.

* Verification of Assumptions: To meet PRS requirements for statistical transparency, the normality of continuous outcomes will be verified using Shapiro-Wilk tests and Q-Q plots. If assumptions are violated, non-parametric methods or log transformations will be employed. * Multiple Testing: To account for testing multiple variables (OHI-S, Knowledge Score, and Behavior), a Bonferroni correction will be applied to the p-values. * Missing Data: If missingness exceeds 5%, Multiple Imputation (m=20) will be used to handle incomplete data.

Outcome Measures The primary clinical endpoint is the Oral Hygiene Index-Simplified (OHI-S), measuring debris and calculus on six tooth surfaces (score 0-6). Secondary endpoints include a 10-item validated Knowledge Score and self-reported behavioral changes in twice-daily brushing frequency from baseline to 12 weeks.

Вмешательства

• Поведенческое Integrated Oral Health Promotion Package (IOHPP)
  The Integrated Oral Health Promotion Package (IOHPP) is an education-based intervention embedded within routine Antenatal Care (ANC). It consists of 1) Two 20-30 minute face-to-face education sessions on maternal/child oral health; 2) Practical demonstrations of modified Bass brushing and flossing techniques; 3) Weekly SMS reminders to reinforce twice-daily brushing and healthy dietary habits; and 4) Distribution of pictorial leaflets and guidelines. ANC providers are trained to provide basic or

Первичные конечные точки

• Change in Oral Hygiene Index-Simplified (OHI-S) score [Срок оценки: Baseline and 12 weeks.]

Вторичные конечные точки (1)

• Change in oral health knowledge scores [Срок оценки: Baseline and 12 weeks.]

Критерии участия

Критерии включения

• Pregnant women attending ANC services at participating UHCs
• Gestational age ≤24 weeks at enrolment to allow follow-up
• Age 18 years or older
• Willing and able to provide informed consent

Критерии исключения

• Presence of severe medical or obstetric complications requiring immediate referral
• Current participation in another behavioural or oral health intervention study
• Conditions preventing participation in oral examination procedures

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Bangladesh · 1 центр

• BSMMU — Dhaka

Публикации

• 16. Roslan D, Ruzlin A, Abdullah N, Azhar Z, Azzani M, Chen X, et al. Application of the PRECEDE-PROCEED model: A glimpse into student-led community health program in Malaysia. Eur J Sustain Dev. 2025;14:335. 10.14207/ejsd.2025.v14n4p335
• Sachelarie L, Iman AEH, Romina MV, Huniadi A, Hurjui LL. Impact of Hormones and Lifestyle on Oral Health During Pregnancy: A Prospective Observational Regression-Based Study. Medicina (Kaunas). 2024 Oct 30;60(11):1773. doi: 10.3390/medicina60111773. PMID 39596958
• 1. Wang S, Jiang J, Li J, et al. The global, regional, and national burden of oral disorders in 204 countries and territories, 1990-2021, and projections to 2050: A systematic analysis for the Global Burden of Disease Study 2021. Regenesis Repair Rehabil. 2025;1(3):56-63 https://doi.org/10.1016/j.rerere.2025.07.001

Идентификаторы

NCT: NCT07507045 · BMU/2026/1575

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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