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Xylitol and the Prevention of Periodontal Disease and Preterm Birth Trial

RecruitingPhase 2, Phase 3Ages any - anyFemaleUniversity of Washington
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In plain words

What the trial is, and whether it could suit you

The ground-breaking Prevention of Prematurity and Xylitol (PPaX) cluster randomized controlled clinical trial was conducted in Lilongwe, Malawi and enrolled approximately 10,069 pregnant individuals seeking to evaluate the impact of xylitol-containing chewing gum compared to no chewing gum on reducing the occurrence of maternal periodontal disease, preterm birth, and low birthweight offspring. The premise of this study centers upon the numerous publications supporting a strong association between maternal periodontal disease and preterm birth. Given that xylitol-containing chewing gum is considered a prebiotic and known to reduce cariogenic and periodontopathic bacteria, the study evaluated and discovered a statistically significant reduction in maternal periodontal disease, preterm birth, and low birthweight offspring among pregnant individuals who chewed xylitol-containing chewing gum.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Able to provide informed consent. For those under 18 years of age, an approval will additionally be sought from the parent or guardian * Less than 20 weeks' gestation (by best obstetric estimate) * At least 20 natural teeth * Planning to deliver at one of the health facilities within the XaPPP trial * Receiving antenatal obstetric care at one of the 8 health districts * Willing to chew two pieces of gum thrice daily for 5 minutes after the morning, day and evening meals throughout pregnancy * Willing to attend all study visits * Willing to provide biospecimens (oral, vaginal, placental, breast milk) * Willing to undergo at least two dental exams including oral microbiota sampling at study enrolment \<20 weeks of pregnancy, 28-30 weeks of pregnancy, and 6-8 weeks after giving birth * Willing to have their child undergo follow up through at least 12 months after birth including neurodevelopmental examination(s) * Speaks Chichewa or English All patients who meet inclusion criteria will be approached without regard to sex, race, ethnicity, parents' country of origin, or religious preferences. Exclusion Criteria: * Those who upon screening and enrolment but dislike the taste of the gum and state they will not chew the gum throughout pregnancy * Gravidae with known or suspected non-viable pregnancy (including life threatening congenital anomalies such as cardiac, neurological or others) * Pregnant individual has a life-threatening diagnosis such as cancer requiring treatment during pregnancy * Pregnant women with a known or suspected morbidly adherent placenta (such as placenta accrete, increta and percreta) * Known allergy to xylitol
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What it tests

  • Xylitol Chewing gum
  • Sorbitol chewing gum
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Where

1 site
Baylor College of Medicine Children's Foundation Malawi
Lilongwe, Malawi
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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