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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorBangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

688 Participants
are divided into 2 treatment groups
Group A: Education-Based InterventionExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

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

Time frame
Baseline and 12 weeks.

Secondary outcomes

1

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.

Time frame
Baseline and 12 weeks.

Other outcomes

1

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.

Time frame
12 weeks.

Sponsors and contacts

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