Periodontal Disease and Preterm Birth

Preterm Birth Clinical Trial

Official title:

Periodontal Disease, Inflammatory Markers, and Preterm Birth

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00582374
• Other study ID #: PeriodontalPreTermBirth
• Status: Withdrawn
• Phase: N/A
• First received: December 19, 2007
• Last updated: March 24, 2017
• Start date: March 2005
• Est. completion date: March 2009

Study information

• Verified date: March 2017
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Gingival Diseases
• Low Birth Weight
• Periodontal Disease
• Periodontal Diseases
• Premature Birth
• Preterm Birth

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the relationship between periodontal disease and upper genital tract inflammation as measured by cytokine levels IL-6, IL-1, and TNF-a and MMP levels from the posterior fornix of the vagina.		4 years
Secondary	To determine whether IL-1ß levels in the oral cavity and the vagina are associated with preterm birth or low-birth weight.		4 years