Education-Based Oral Health Promotion Intervention During Pregnancy: Implementation Protocol in Bangladesh (E-OHP)

Oral Health Promotion Intervention During Pregnancy: Bangladesh Perspective

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Periodontal Diseases; Pregnancy; Oral Hygiene, Oral Health
• Intervention / Treatment: Behavioral: Integrated Oral Health Promotion Package (IOHPP)

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.

• Study Type: Interventional
• Enrollment (Estimated): 688
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nabhira Aftabi Binte Islam, BDS,MPH; Phone Number: +8801717481594; Email: nabhira22@bsmmu.edu.bd
• Study Contact Backup: Name: Md. Atiqul Haque Prof., PhD; Phone Number: +8801711428141

Study Locations

• Bangladesh
  • Dhaka, Bangladesh, 1000
    • BSMMU
    • Contact: Nabhira Aftabi Binte Islam, BDS, MPH; Phone Number: 01717481594; Email: nabhira22@bsmmu.edu.bd
    • Contact: Email: nabhira22@bsmmu.edu.bd
    • Principal Investigator: Nabhira Aftabi Binte Islam, BDS, MPH
    • Sub-Investigator: Anika Tasnim, MBBS, MPH
    • Sub-Investigator: Md Atiqul Haque, PHD, MPH, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Education-Based Intervention; Participants at the four intervention Upazila Health Complexes (UHCs) will receive routine antenatal care (ANC) plus a structured oral health package. This includes two face-to-face education sessions, tooth-brushing and flossing demonstrations, weekly SMS reminders, and pictorial educational materials.	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 oral health counseling and facilitate referrals to dental services. The model uses the PRECEDE-PROCEED framework to address social and behavioral determinants of health in a low-resource setting.
No Intervention: Usual Care; Participants at the four control Upazila Health Complexes (UHCs) will receive the standard National Antenatal Care (ANC) services currently provided by the government of Bangladesh without the additional oral health education package.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Oral Hygiene Index-Simplified (OHI-S) score	The OHI-S assesses oral hygiene through two components: Debris Index (DI-S) and Calculus Index (CI-S). Six tooth surfaces are examined. The total score ranges from 0 to 6. A score of 0.0-1.2 is Good; 1.3-3.0 is Fair; 3.1-6.0 is Poor	Baseline and 12 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in oral health knowledge scores	Measured using a structured composite scale assessing knowledge of maternal oral health, hygiene practices, and disease prevention. The scale ranges from 0 to [Insert your Max Score], where higher scores indicate better knowledge.	Baseline and 12 weeks.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of women brushing twice daily	Calculated as the percentage of participants who self-report brushing their teeth at least twice per day over the previous 7 days using an interviewer-administered questionnaire.	12 weeks.

Collaborators and Investigators

• Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Publications and helpful links

General 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
• 2. Sachelarie L, Iman A el haj, 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;60(11):1773. 10.3390/medicina60111773
• 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

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: March 12, 2026
• First Submitted That Met QC Criteria: March 29, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 29, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cluster randomized trial; Pregnancy; Antenatal care; Maternal oral health
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Periodontal Diseases
• Other Study ID Numbers: BMU/2026/1575

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The IPD will be shared after completion of the study through the Zotero data repository
• IPD Sharing Time Frame: 1st may to 31st August 2026
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No