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

March 29, 2026 updated by: Md Atiqul Haque, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
688

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Md. Atiqul Haque Prof., PhD
  • Phone Number: +8801711428141

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh, 1000
        • BSMMU
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nabhira Aftabi Binte Islam, BDS, MPH
        • Sub-Investigator:
          • Anika Tasnim, MBBS, MPH
        • Sub-Investigator:
          • Md Atiqul Haque, PHD, MPH, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Oral Hygiene Index-Simplified (OHI-S) score
Time Frame: Baseline and 12 weeks.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in oral health knowledge scores
Time Frame: Baseline and 12 weeks.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of women brushing twice daily
Time Frame: 12 weeks.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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