Periodontal Disease and Preterm Birth

Periodontal Disease, Inflammatory Markers, and Preterm Birth

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.

Study Overview

• Status: Withdrawn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

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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women from the OU Medical Center Women's Clinic

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
A; Pregnant Women

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time 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 Outcome Measures

Outcome Measure	Time 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

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Eric Knudtson, MD, University of Oklahoma

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (Anticipated): March 1, 2009
• Study Completion (Anticipated): March 1, 2009

Study Registration Dates

• First Submitted: December 19, 2007
• First Submitted That Met QC Criteria: December 27, 2007
• First Posted (Estimate): December 28, 2007

Study Record Updates

• Last Update Posted (Actual): March 28, 2017
• Last Update Submitted That Met QC Criteria: March 24, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Pregnancy; Preterm Birth; Periodontal Disease; Low Birth Weight
• Additional Relevant MeSH Terms: Body Weight; Stomatognathic Diseases; Mouth Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Birth Weight; Periodontal Diseases
• Other Study ID Numbers: PeriodontalPreTermBirth