A cluster randomized trial of xylitol chewing gum for prevention of preterm birth: The PPaX trial.
Level 2 - randomized trial
Cluster randomized controlled trial
PubMed 39541971 · doi:10.1016/j.medj.2024.10.016
What was done
In an open-label, parallel-enrollment, matched-pair, cluster-randomized controlled trial across eight health center sites in Lilongwe, Malawi, sites were paired by anticipated delivery volume and assigned to prenatal and oral health education alone (active control) or education plus twice-daily xylitol chewing gum throughout periconception and pregnancy. Co-primary outcomes were primary prevention of preterm birth (<37 weeks) and low-birthweight delivery (<2,500 g), evaluated using generalized linear mixed models with site as a random factor.
What was found
The trial enrolled 10,069 participants (4,549 intervention, 5,520 control) with over 95% available for analysis. Xylitol gum significantly reduced preterm birth (12.6% [549/4,349] vs. 16.5% [878/5,321]; RR 0.76, 95% CI 0.57-0.99), low-birthweight neonates (8.9% [385/4,305] vs. 12.9% [679/5,260]; RR 0.70, 95% CI 0.49-0.99), and neonatal demises (0.2% [8/4,305] vs. 0.4% [22/5,260]; RR 0.41, 95% CI 0.19-0.89).
Why it matters
While dental procedures like scaling and root planing during pregnancy have failed to prevent adverse birth outcomes in previous trials, this study demonstrates that a low-cost, non-invasive oral health intervention initiated periconception can reduce preterm and low-birthweight births.
Limits
The intervention was open-label. Only eight cluster sites were randomized, which increases vulnerability to residual cluster-level confounding. Results from this high-prevalence population in Malawi may not generalize to other demographics, and adherence and adverse effects were not reported in the abstract.