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Periodontal Disease and Preterm Birth

Periodontal Disease, Inflammatory Markers, and Preterm Birth

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00582374
Enrollment
0
Registered
2007-12-28
Start date
2005-03-31
Completion date
2009-03-31
Last updated
2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Birth Weight, Periodontal Disease, Preterm Birth

Keywords

Periodontal Disease, Preterm Birth, Low Birth Weight, Pregnancy

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

University of Oklahoma
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* Between the ages of 15-35 * Singleton gestation

Exclusion criteria

* Diabetes prior to pregnancy * Require antibiotic prophylaxis prior to dental treatment * Require steroids during pregnancy

Design outcomes

Primary

MeasureTime frame
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.4 years

Secondary

MeasureTime frame
To determine whether IL-1β levels in the oral cavity and the vagina are associated with preterm birth or low-birth weight.4 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026