Pregnancy-associated Gingivitis Clinical Trial
Official title:
A Study of Oral Health Care Education and Therapy to Reduce Gingivitis During Pregnancy
Compelling evidence suggesting a possible link between maternal pregnancy-related
periodontitis (gum disease) and spontaneous pre-term birth (PTB)makes effective management
of oral health a relevant and significant obstetrical-dental issue.
The purpose of this pilot study is to determine whether intensive education and counseling
can help pregnant women learn to maintain excellent oral health and in doing so reduce the
severity of gingivitis and periodontitis during their pregnancy. Failure to effectively
remove the plaque biofilm from the surface of teeth every day is the crucial event leading
to the development of gingivitis and plaque-induced gingivitis is the most common form of
periodontal disease in pregnant women.
We therefore hypothesize that patients can be taught to effectively modulate their own
disease through intensive education and meticulous home care coupled with closely monitored
behavior modification.
We believe this may be an effective approach toward improving oral health with the potential
to reduce adverse pregnancy outcomes.
Adverse pregnancy outcomes are significant personal and public health issues in the United
States where approximately 12% of all births are pre-term (<37 weeks gestation). Care for
these neonates accounts for over 5 million neonatal intensive care hospital stays each year
and close to $6 Billion in annual health care costs. Premature delivery and low birth weight
(LBW) are leading determinates of neonatal mortality and serious morbidity often leading to
neurological and developmental restrictions in early childhood. Concomitant to these data
are significant social and psychological consequences related to maternal and family
distress and the effects of personal loss.
The role of maternal periodontitis as a potential stressor having detrimental effects on
pregnancy outcomes is a relatively new area of investigation. Nevertheless, increasing
evidence exists to support an association between maternal periodontal disease, a chronic
anaerobic inflammatory condition of the oral cavity, and adverse pregnancy outcomes
including pre-term birth (PTB) and fetal growth restriction. This is particularly true with
very early-in-gestation delivery.
After adjusting for age, race, smoking and parity, a prospective study of over one-thousand
pregnant women conducted at the University of Alabama at Birmingham (UAB) demonstrated that
periodontal disease is associated with an increased risk of pre-term birth (PTB) by an odds
ratio 4-7, depending on disease severity. These data showed a 55% prevalence of periodontal
disease among this cohort; a much higher prevalence than had been reported in national
surveys.
The mechanisms responsible for this association remain unclear. However, substantial data
suggest that systemic inflammation, as measured by serum C-reactive protein and other
inflammatory mediators may well underlie the observed associations.
Investigators hypothesize that links between maternal infections and pre-term bith involve
microbes and host response to microbes that enter the uterine cavity during pregnancy. In
cases of remote infection, such as periodontitis, this may occur via a blood-bourne route
which triggers an alteration in the normal cytokine and hormone regulatory gestation that
can result in premature labor, early rupture of membranes and preterm birth.
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Observational Model: Case-Only, Time Perspective: Prospective