Saving Lives at Birth: Primary Prevention of Periodontal Disease in Relation to Preterm Birth in Malawi

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.

Inclusion Criteria:

1. Enrollment at <20 weeks gestation by best obstetrical estimate, or

2. Enrollment post partum with an anticipated next pregnancy within 18 months, or

3. Enrollment preconception with an anticipated pregnancy within 18 months
(preconception); and

4. Cognitively aware enough to participate in the study

5. >18 years of age (in Malawi, constitutes a legal adult and capacity to consent for
study)

6. Willing to participate in the study

7. Willing to undergo at least two periodontal exams

8. Willing to chew 1 piece of xylitol gum for 10 minutes after the morning and evening
meal (intervention sites)

9. Anticipating to remain within the region for 18 months

Exclusion Criteria:

1. >20 weeks gestation by best obstetrical estimate

2. Post partum and not anticipating another pregnancy within 18 months

3. Preconception and not anticipating another pregnancy within 18 months

4. Not cognitively aware enough to participate in the study

5. Not willing to undergo at least two periodontal exams

6. <18 years of age

7. Not willing to chew 1 piece of xylitol gum for 10 minutes after the morning and
evening meal (intervention sites)

8. Anticipating a move outside of the region within 18 months