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

NCT07507045 | Not Yet Recruiting

• 1 other identifier: BMU/2026/1575
• Study Type: interventional
• Target: 688
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy; Periodontal Diseases; Oral Hygiene, Oral Health

Keywords

Maternal oral health; Pregnancy; Antenatal care; Cluster randomized trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in oral health knowledge scores

  Baseline and 12 weeks.

Other Outcomes (1)

• Proportion of women brushing twice daily

  12 weeks.

Study Arms (2)

Education-Based Intervention

EXPERIMENTAL

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)

Usual Care

NO INTERVENTION

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.

Interventions

Integrated Oral Health Promotion Package (IOHPP) BEHAVIORAL

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.

Education-Based Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

BSMMU

Dhaka, 1000, Bangladesh

Location

Related Publications (3)

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Nabhira Aftabi Binte Islam, BDS,MPH

CONTACT

+8801717481594; nabhira22@bsmmu.edu.bd

Md. Atiqul Haque Prof., PhD

CONTACT

+8801711428141

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: April 2, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 1st may to 31st August 2026

Locations

BA (1)