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

Sponsor
Johns Hopkins Bloomberg School of Public Health
Study ID
NCT07553286
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
15 Years - 35 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

First listed
Apr 27, 2026
Start date
Oct 1, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
2,280 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • No Intervention: Control arm
    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.
  • Experimental: Package of oral health interventions
    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.

Primary Outcome Measure

Proportion of small vulnerable newborn births [ Time Frame: At the time of delivery. ]

Central Contacts

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