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

Official title

Oral Health Promotion Intervention During Pregnancy: Bangladesh Perspective

Overview

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.

Detailed description

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.

Interventions

• Behavioral 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

Primary outcome measures

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

Secondary outcome measures (1)

• Change in oral health knowledge scores [Time frame: Baseline and 12 weeks.]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Bangladesh · 1 center

• BSMMU — Dhaka

Publications

• 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

Identifiers

NCT: NCT07507045 · BMU/2026/1575

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗