An interventional study of Integrated Oral Health Promotion Package (IOHPP) in Pregnancy, Periodontal Diseases and Oral Hygiene, Oral Health, sponsored by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh. Not yet recruiting at 1 site in Bangladesh. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · Not applicable, Interventional, and Prevention
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 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.
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.
867 studies on the registry are indexed under Periodontal Diseases; 189 are open to participants now.
This study's planned enrollment of 688 is above the median of 45 across 557 interventional studies indexed under Periodontal Diseases.
Browse Periodontal Diseases studies →Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh is the lead sponsor of 128 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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.
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.
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.
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.
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.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — The IPD will be shared after completion of the study through the Zotero data repository
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: 1st may to 31st August 2026
Start is estimated for Jun 2027; primary completion for Nov 2027, 5 months later.
Of 312 non-industry interventional studies with no phase under Periodontal Diseases, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 27. This study's planned 5 months is below that.
Counting every sponsor, half of 331 studies reached it within 13 months; a quarter within 8 and three quarters within 26.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 21, 2026: start May 2026 → Jun 2027, primary completion Aug 2026 → Nov 2027 and completion Nov 2026 → Jan 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh →