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ClinicalTrials.gov Identifier: NCT00582374
Recruitment Status :
(PI passed away unexpectedly)
To determine the relationship between periodontal disease and upper genital tract inflammation in pregnancy. To determine whether certain fluid levels in the oral cavity and the vagina are associated with preterm birth or low-birth weight.
Condition or disease
Periodontal DiseasePreterm BirthLow Birth Weight
Patients will be enrolled in the study at their first prenatal visit after the details of the study have been discussed. Potential subjects will be presented with a questionnaire to determine eligibility for the study. The patient will be scheduled for an exam between 18-24 weeks at which time they will undergo a periodontal assessment, to determine the presence or absence of periodontal disease, a sampling of gingival crevicular fluid (GCF) and a vaginal swab collection. Periodontal disease will be determined by measuring the depth of gingival sulci, amount of periodontal attachment loss, and prevalence of gingival bleeding at six sites for each tooth present.
To determine the relationship between periodontal disease and upper genital tract inflammation as measured by cytokine levels IL-6, IL-1, and TNF-α and MMP levels from the posterior fornix of the vagina. [ Time Frame: 4 years ]
Secondary Outcome Measures :
To determine whether IL-1β levels in the oral cavity and the vagina are associated with preterm birth or low-birth weight. [ Time Frame: 4 years ]
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Ages Eligible for Study:
15 Years to 35 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Pregnant women from the OU Medical Center Women's Clinic
Between the ages of 15-35
Diabetes prior to pregnancy
Require antibiotic prophylaxis prior to dental treatment