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Periodontal Disease and Preterm Birth

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ClinicalTrials.gov Identifier: NCT00582374
Recruitment Status : Withdrawn (PI passed away unexpectedly)
First Posted : December 28, 2007
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Periodontal Disease Preterm Birth 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 Design

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Periodontal Disease, Inflammatory Markers, and Preterm Birth
Study Start Date : March 2005
Estimated Primary Completion Date : March 2009
Estimated Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
A
Pregnant Women


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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 ]

Biospecimen Retention:   None Retained
Gingival crevicular fluid (GCF) and Vaginal Fluid

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 35 Years   (Child, Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00582374     History of Changes
Other Study ID Numbers: PeriodontalPreTermBirth
First Posted: December 28, 2007    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017

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

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