Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial

NCT07553286 | Not Yet Recruiting Phase 3 DMC

• 2 other identifiers: IRB000355561R01HD119055
• Study Type: interventional
• Target: 2,280
• Locations: 0 countries
• Sites: N/A

Brief Summary

Periodontal disease in pregnant women has been implicated as a potential risk factor for adverse pregnancy outcomes, including being born preterm, small-for-gestational age, and/or low birth weight. Infants who have at least one of these outcomes, known as small vulnerable newborns (SVN)), are at increased risk of early death and poor infant growth and development. Rigorous, high-quality randomized trials are needed to evaluate whether improving the periodontal health of pregnant women can reduce the risk of adverse pregnancy outcomes in areas like South Asia, where these outcomes are common and neonatal mortality remains high. This study is a community-based, randomized controlled trial (n=2,280) to evaluate a package of oral health interventions delivered to pregnant women in the first trimester until delivery on the incidence of SVNs in rural Sarlahi District, Nepal. The intervention package will include a daily antiseptic oral rinse and intensive oral hygiene education and instruction. Both intervention and control groups will be provided a manual toothbrush and toothpaste. The investigators will determine intervention effects on incidence of SVNs and individual outcomes of preterm birth, small-for-gestational age, and low birth weight. In a biospecimen sub-study (n=200), the investigators will collect venous blood, gingival crevicular fluid, and plaque in early and late pregnancy to explore relationships between subgingival inflammation, systemic inflammation, and SVN types and other adverse pregnancy outcomes. If efficacious, a low-cost package of oral health interventions - including an antiseptic oral rinse, intensive oral hygiene education and instruction, and provision of a manual toothbrush and toothpaste - could improve maternal and newborn outcomes at this critical time of growth and development.

Conditions

Preterm Birth; Small Vulnerable Newborn; Small-for-gestational Age; Periodontal Disease; Low Birth Weight

Keywords

Nepal; Oral health; Small Vulnerable Newborns; Preterm birth; Periodontal disease; Low birth weight; Small-for-gestational age; Pregnancy; Antenatal care; Dental health; Gingivitis; Antiseptic oral rinse; Oral hygiene

Outcome Measures

Primary Outcomes (1)

• Proportion of small vulnerable newborn births

  The primary trial outcome is the proportion of live births classified as small vulnerable newborn (SVN), defined as a composite of preterm birth (PT; \<37 weeks' gestation), small-for-gestational age (SGA; birth weight \<10% for gestational age and sex using the INTERGROWTH-21st reference standard), and/or low birth weight (LBW; \<2,500g). A live-born infant meeting at least one of these criteria will be classified as an SVN birth.

  At the time of delivery.

Secondary Outcomes (4)

• Proportion of small vulnerable newborn types

  At the time of delivery.

• Proportion of preterm births

  At the time of delivery.

• Proportion of small-for-gestational age (SGA) births

  At the time of delivery.

• Proportion of low birth weight births

  At the time of delivery.

Other Outcomes (2)

• Change from Early to Late Pregnancy in the Proportion of Participants With Periodontal Disease

  Early pregnancy (<14 weeks' gestation), late pregnancy (approximately 32-34 weeks)

• Change From Early to Late Pregnancy in Mean Gingival Crevicular Fluid Inflammatory Mediator Levels

  Early pregnancy (<14 weeks' gestation), late pregnancy (approximately 32-34 weeks)

Study Arms (2)

Control arm

NO INTERVENTION

Pregnant women randomized to the control group will receive basic oral health information and a manual toothbrush and toothpaste. Basic oral health information will consist of a short brief at enrollment about oral hygiene, including brushing twice daily, not smoking, avoiding sugary foods and beverages, and the importance of preventive dental care. The investigators do not anticipate this will impact the exposure or outcome.

Package of oral health interventions

EXPERIMENTAL

Pregnant women randomized to the intervention group will receive a home-based package, including antiseptic oral rinse (alcohol-free cetylpyridinium chloride (CPC) (0.075%)), intensive oral hygiene instruction, and a manual toothbrush and toothpaste.

Drug: A package of oral health interventions, including a daily antiseptic oral rinse (alcohol-free cetylpyridinium chloride (0.075%))

Interventions

A package of oral health interventions, including a daily antiseptic oral rinse (alcohol-free cetylpyridinium chloride (0.075%)) DRUG

The oral health intervention package will be home-based and will include a daily antiseptic oral rinse (alcohol-free cetylpyridinium chloride (CPC) (0.075%)), intensive oral hygiene instruction, and a manual toothbrush and toothpaste. Participants will rinse twice daily with 10 ml after brushing teeth for 1 minute. A one-on-one oral hygiene education session will be delivered at the participant's home lasting about one hour. Instruction will cover the basics of periodontal disease and dental caries, risk factors for these conditions, and proper oral hygiene behaviors, including use of toothbrushing and toothpaste, interdental cleaning, and antiseptic mouthwash. The session will include a demonstration by the data collector and time for the participant to practice the behaviors. An instructional pictorial guide in Nepali or Maithili, depending upon the participant's language, will be left with the participant.

Package of oral health interventions

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Married women of reproductive age (15-35 years).
• Living in the study area who are pregnant and consent to participate.

You may not qualify if:

• Currently pregnant women.
• Women who are sterilized or use long-acting contraceptive methods or are divorced or widowed.
• Women identified as pregnant ≥12 gestational weeks based upon date of last menstrual period.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

MeSH Terms

Conditions

Premature Birth; Periodontal Diseases; Gingivitis

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Daniel Erchick, PhD

  Johns Hopkins Bloomberg School of Public Health, Department of International Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel J Erchick, PhD

CONTACT

410-955-3934; derchick@jhu.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The investigators will try to mask outcome assessors to participant's allocation to the extent possible.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 27, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04