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Periodontal Disease and Preterm Birth

This study has been terminated.
Sponsor:
Information provided by:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00582374
First received: December 19, 2007
Last updated: December 11, 2008
Last verified: June 2008
History of Changes
  Purpose

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
Periodontal Disease
Preterm Birth
Low Birth Weight

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Periodontal Disease, Inflammatory Markers, and Preterm Birth

Resource links provided by NLM:

MedlinePlus related topics: Birth Weight
U.S. FDA Resources

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Gingival crevicular fluid (GCF) and Vaginal Fluid


Estimated Enrollment: 300
Study Start Date: March 2005
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
A
Pregnant Women

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.

  Eligibility

Ages Eligible for Study:   15 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pregnant women from the OU Medical Center Women's Clinic

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00582374

Locations
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Eric Knudtson, MD University of Oklahoma
  More Information

No publications provided

Responsible Party: Eric Knudtson, MD, University of Oklahoma Health Sciences Center
ClinicalTrials.gov Identifier: NCT00582374     History of Changes
Other Study ID Numbers: PeriodontalPreTermBirth
Study First Received: December 19, 2007
Last Updated: December 11, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
Periodontal Disease
Preterm Birth
Low Birth Weight
Pregnancy

Additional relevant MeSH terms:
Birth Weight
Periodontal Diseases
Premature Birth
Body Weight
Signs and Symptoms
 Mouth Diseases
Stomatognathic Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on May 21, 2013