Periodontal Disease and Preterm Birth

Withdrawn

• Conditions: Periodontal Disease; Preterm Birth; Low Birth Weight

• Registration Number: NCT00582374
• Lead Sponsor: University of Oklahoma

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.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-27
• Study First Posted: 2007-12-28
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-24
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States