PregnancyE-OHPNCT07507045
Education-Based Oral Health Promotion Intervention During Pregnancy: Implementation Protocol in Bangladesh
A study testing Integrated Oral Health Promotion Package (IOHPP) in people with Pregnancy and Periodontal Diseases, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Periodontal Diseases, Oral Hygiene, Oral Health
- What is being tested?
- Integrated Oral Health Promotion Package (IOHPP)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 688 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Jun 2027to 1 Jan 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Md. Atiqul Haque Prof., PhD contact
Bangladesh1 site
BSMMU
Dhaka, 1000
Nabhira Aftabi Binte Islam, BDS, MPH, 01717481594, nabhira22@bsmmu.edu.bd
nabhira22@bsmmu.edu.bd
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy, Periodontal Diseases, Oral Hygiene, Oral Health
- Being tested
- Integrated Oral Health Promotion Package (IOHPP)
- Keywords
- Maternal oral health, Pregnancy, Antenatal care, Cluster randomized trial
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Oral Health Promotion Package (IOHPP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Baseline and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 Jun 2027 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 688 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Md Atiqul Haque, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507045
- Sponsor's protocol ID
- BMU/2026/1575
- Acronym
- E-OHP
- Status last verified
- Oct 2026
- First submitted
- 12 Mar 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD will be shared after completion of the study through the Zotero data repository
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.
PubMed 395969581. 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