E.W. "Al" Thrasher
Status: Funded - Open
Saving lives at birth: Primary prevention of periodontal disease & preterm birth in Malawi
Kjersti Aagaard, M.D., Ph.D.
BACKGROUND: Adverse birth outcomes related to the length of gestation (preterm birth) are recognized as one of the most significant disorders in maternal-child health at a global scale. In the developed world, the preterm birth rate approximates 7%. In Malawi, we have recently demonstrated that this rate more than triples to approximate 26.1%.
GAP: The link between maternal oral health (periodontal disease in particular) and risk of preterm birth has been demonstrated across all populations (rural and urban, in both industrialized and developing regions) studied to date. However, in multiple randomized controlled trials treatment of active periodontal disease with scaling and planning during pregnancy has failed to demonstrate a significant benefit in preventing preterm birth. So if we know that there is biologic evidence that periodontitis is related to preterm birth, but treating active periodontitis does not reduce these morbidities, is it possible that preventing periodontitis might prevent preterm birth and low birth weight?
HYPOTHESIS: Our overarching hypothesis is that comprehensive primary preterm birth prevention, inclusive of maternal oral health with xylitol chewing gum (the intervention), will reduce the rate of periodontal disease and caries, preterm birth prevalence, and neonatal mortality.
METHODS: This is a cluster randomized trial in a 54 km urban-rural region surrounding Lilongwe, Malawi. In our cluster randomized design (where the health center serves as the unit of randomization), we have accounted for a 30% loss to follow up and calculated our per site enrollment to necessitate 1170 subjects at each of 8 sites (where site is defined as the antenatal health center, and there are 4 intervention and 4 non-intervention sites). Our study design enables us to directly assess the relationship between exposure to the intervention (xylitol containing chewing gum) and incidence of two outcomes: 1) preterm birth and 2) rate and severity of periodontal disease.
IMPACT: Not only is being born too soon a leading cause of infant morbidity and mortality, but for those that do survive, there are persistent and lifelong risks due to chronic infection and lung underdevelopment.
Preventing Prematurity, Prospective Cohort, Human, Randomized Clinical Trial
Texas Children's Hospital
United States, Malawi