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

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

Interventions

DRUG

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

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.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• Johns Hopkins Bloomberg School of Public Health

  lead OTHER

Principal Investigators

• Daniel Erchick, PhD · Johns Hopkins Bloomberg School of Public Health, Department of International Health

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

35 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2028-12-31

Completion

2028-12-31