Saving Lives at Birth: Primary Prevention of Periodontal Disease in Relation to Preterm Birth in Malawi
Condition: Preterm Birth; Periodontal Disease; Caries, Dental
MeSH terms: Periodontal Diseases; Dental Caries; Premature Birth
Study type: Interventional

Summary: 
      The hypothesis of the investigators' project 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.
    

Detailed description: 
      Significance and Impact: 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, the
      investigators have recently demonstrated that this rate more than triples to approximate
      26.1%. Of the 4 million newborn deaths annually, nearly 1/3 (27%) are directly attributable
      to prematurity with another 36% secondary to related opportunistic infections (sepsis,
      pneumonia, gastrointestinal). 75% of the 4 million deaths occur within the first week of
      life, with the vast majority occurring in the first 48 hours. For those that do survive,
      there are persistent and lifelong risks due to stunted growth, chronic infection, retinopathy
      of prematurity, and bronchopulmonary dysplasia. 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.

      Why would maternal oral health impact preterm birth? In rodents, subcutaneous inoculations
      with periodontal pathogens cause dose-dependent decreases in pup weights, and elicit
      inflammatory responses that can trigger preterm birth when present in amniotic fluid.
      Periodontitis (defined as a destructive inflammation of the periodontium) has a prevalence of
      30% or greater in women of child bearing age. By definition, it involves microbial
      infiltration of the periodontium, which stimulates a chronic inflammatory response, recurrent
      bacteremia, and the production of cytokines and prostaglandins which trigger risk of preterm
      birth. It is the same production of prostaglandins which are felt to mediate the risk of
      preterm birth. So if the investigators 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? If so, what are the least expensive efficacious preventative measures?
      The investigators' 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.
    

Intervention name(s): Xylitol gum
Intervention type(s): Dietary Supplement
Intervention description(s): This is a cluster randomized trial, whereby 4 sites will receive the intervention of xylitol gum in the prepregnancy and early pregnancy interval.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention