Clinical trial NCT00641901: A Study to Evaluate Associations Between Gingivitis and Pregnancy Outcomes
Official title: A Study of Oral Health Care Education and Therapy to Reduce Gingivitis During Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy-associated Gingivitis
Keywords: gingivitis
pregnancy
pre-term birth
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2008-03-24
Enrollment: 120
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Center for Women's Reproductive Heath at UAB

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Confirmed pregnancy between 16 and 24 weeks gestation
* Minimum of 20 natural teeth
* Gingival inflammation 50% of teeth

Exclusion Criteria:

* Multiple gestations
* Positive history for HIV infection, AIDS, Diabetes Mellitus
* Rampant untreated caries
* Concomitant Orthodontic treatment
* Medical condition that requires antibiotic prophylaxis prior to dental treatment
* Chronic use of medication that may cause gingival hypertrophy
* Chronic use of steroids
* Any obstetrical contraindication

Primary outcomes:
measure: Reduced gingival inflammation
timeFrame: 8 weeks
Secondary outcomes:
measure: Reduced pre-term birth
timeFrame: 40 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The Center for Women's Reproductive Health at UAB
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Michael S Reddy, DMD, DMSc
role: PRINCIPAL_INVESTIGATOR
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