LB 1: PPaX: Cluster randomized trial of xylitol chewing gum on prevention of preterm birth in Malawi

Abstract

Studies have shown an association between maternal periodontal disease and preterm birth (PTB), but randomized trials of dental scaling/planing in pregnancy have not demonstrated preventative benefit. Xylitol chewing gum reduces dental caries, but its effect on improving periodontal health and reducing PTB is unknown. Hypothesizing that daily xylitol gum use starting periconception would reduce periodontitis and PTB, we undertook a cluster randomized trial in Malawi, the country with the highest known PTB rate (22%). This was a multicenter, open label, cluster randomized trial enrolling subjects from 8 health centers spanning a 79 km urban-rural region in Lilongwe, Malawi over 6 years with follow up of 28 days postpartum. Subjects were consented & enrolled pre-pregnancy or < 20 weeks gestation. Four centers were randomized to group perinatal and oral health education plus daily xylitol chewing gum use (intervention), and compared to 4 centers randomized to only education (control). Analysis of significant impact on the primary outcomes delivery < 37 weeks and/or < 2500 grams was by group allocation (xylitol vs control) following adjustment for confounders. 10,069 women were enrolled (4549 intervention & 5520 control) with 9,670 outcomes available at follow-up. Perinatal xylitol chewing gum use resulted in a significant PTB reduction (12.6% vs. 16.5%; aRR 0.76, 95% CI 0.59-0.99) and fewer < 2500g neonates (8.9% vs 12.9%; aRR 0.70, 95% CI 0.49-0.99), largely attributable to reducing late PTB (34-36 6/7 weeks; 9.9% vs 13.5%, aRR 0.73, 95% CI 0.53-0.99; Table 1). Among n=4220 subjects compliant with dental visits, a significant reduction in periodontitis occurred with xylitol gum use (p=0.03 vs p=0.29, Fig.1). In a cluster randomized trial in Malawi, periconception initiation and use of xylitol chewing gum resulted in a reduced incidence of PTB and < 2500g newborns, predominately due to significantly fewer late PTBs and in association with less periodontitis. To prevent a case of PTB, 26 patients would need to chew daily xylitol gum at an estimated retail cost of $1087.View Large Image Figure ViewerDownload Hi-res image Download (PPT)