A cluster randomized trial of xylitol chewing gum for prevention of preterm birth: The PPaX trial

Maternal periodontal disease is associated with preterm and low-birthweight deliveries, but randomized trials of likely efficacious treatments (e.g., dental scaling and root planing) during pregnancy have not reduced these adverse outcomes. As an alternative, we hypothesized that periconception initiation of xylitol chewing gum would reduce the occurrence of preterm or low-birthweight deliveries among a historical high-prevalence population in Malawi. We conducted an open-label, parallel-enrollment, matched-pair, cluster-randomized, controlled clinical trial across eight health centers (sites) in and around Lilongwe, Malawi. Sites were paired by anticipated delivery volume and randomized to prenatal and oral health education alone (active control) or with twice-daily xylitol chewing gum (intervention) throughout the periconception and antenatal periods. For the primary prevention of preterm (<37 weeks) and low-birthweight (<2,500 g) deliveries (co-primary outcomes), comparison by allocation group was performed using generalized linear mixed models for each outcome as a fixed factor and the site(s) as a random factor. 10,069 participants were enrolled ( n = 4,549 at intervention sites, n = 5,520 at active control sites), with >95% available for analyses. Initiation of xylitol chewing gum resulted in significant reductions in the co-primary outcomes: preterm birth (12.6% [549/4,349] vs. 16.5% [878/5,321]; relative risk [RR] 0.76, 95% confidence interval [CI] 0.57–0.99) and <2,500-g neonates (8.9% [385/4,305] vs. 12.9% [679/5,260]; RR 0.70, 95% CI 0.49–0.99). Xylitol chewing gum use also led to fewer neonatal demises (0.2% [8/4,305] vs. 0.4% [22/5,260]; RR 0.41, 95% CI 0.19–0.89). Periconception initiation and ongoing use of xylitol chewing gum significantly reduced the occurrence of preterm and low-birthweight deliveries in Malawi. E.W. Al Thrasher Foundation (to K.A.) and USAID Saving Lives at Birth Grand Challenges Grant AID-OAA-G-11-00062 (to K.A.). Additional financial and in-kind support was graciously provided by Texas Children’s Hospital and Baylor Foundation Malawi. • Xylitol chewing gum use during pregnancy reduced preterm and low-birthweight deliveries • Compared to active controls, xylitol chewing gum use led to fewer neonatal demises • No significant adverse events were reported with xylitol chewing gum use in pregnancy While periodontal disease in pregnancy is associated with the delivery of preterm and low-birthweight newborns, trials of routine treatment strategies have not shown significant benefit. Here, investigators evaluated the use of xylitol-containing chewing gum among 10,069 pregnant participants in an eight-site cluster randomized trial in Malawi, a country with one of the highest preterm birth rates. Compared to an active control group receiving education and Malawi Ministry of Health standard prenatal care, early pregnancy initiation and ongoing use of xylitol-containing chewing gum twice daily reduced the occurrence of preterm and low-birthweight deliveries. In order to prevent one such occurrence, fewer than 26 gravidae needed xylitol chewing gum use, making it efficacious and affordable in a low-resource setting. Valentine et al. conducted an open-label, parallel-enrollment, matched-pair, cluster-randomized trial of 10,069 pregnant participants from eight randomization sites in Malawi. When compared to active controls receiving perinatal and oral health messages, addition of xylitol-containing chewing gum during early pregnancy significantly reduced preterm and low-birthweight deliveries, reducing neonatal mortality.

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