- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00490165
Periodontal and Periapical Inflammation and Pregnancy
Associations Between Periodontal and Periapical Inflammation and Pregnancy Outcomes
Study Overview
Status
Detailed Description
A. Specific Aims
- To determine possible associations between periapical oral infection and adverse pregnancy outcomes in female patients in the School of Dentistry, the Dental/Dental Emergent Care Clinic (Jackson Medical Mall), and the UMC Hospital.
- To examine the effects of several confounding variables related to stress from pain from the periapical infections on these adverse outcomes.
B. Background and Significance
During the past five years there has been increasing evidence for associations between periodontal infection and adverse pregnancy outcomes in humans, including preterm birth, low birth-weight babies, gestational diabetes, miscarriage, and preeclampsia. These events likely result from oral infections because bacteremia and release of pro-inflammatory cytokines from the diseased oral sites have been described.
Proinflammatory cytokines have been reported to be harmful and destructive to a successful pregnancy. The adverse fetal inflammatory response to TNF-alpha, IL-6 and C-reactive protein has been associated with preterm birth. These cytokines are also commonly associated with oral infections, both periodontal and periapical11. In addition, oral infections often produce pain and stress, which are considered harmful to a successful pregnancy. Since the effects of periodontal infections on adverse pregnancy outcomes have been described, it would be worthwhile to examine the specific effects of oral periapical abscesses on adverse birth outcomes, to begin to determine whether there is an association between this type of oral infection and these adverse outcomes.
There is no published information concerning the possible associations of tooth abscesses on pregnancy outcomes. In addition, there is no known biological mechanism for the direct link between periodontal infections, pre-term birth and low birth-weight babies. Secondary factors such as age, race, and life-style likely confound assessment of these associations. There are some preliminary studies of these variables in regard to the association between periodontal infections and adverse pregnancy outcomes, but not for periapical lesions. Since periapical lesions produce pain, these secondary factors could be more important to pregnancy outcomes than the primary factors (bacteria and proinflammatory cytokines).
C. Data collection. Archived dental records from female patients treated during the past three years at the University of Mississippi School of Dentistry and the Dental/Dental Emergent Care Clinic (Jackson Medical Mall) will be examined. Each patient record will be assigned a study number, and data will be entered on an Excel spreadsheet using that study number. Since the pregnancy outcome is part of the UMC Hospital record, the principal investigator will link the dental and hospital records using the patient name. However, the data collected will use a research number. Following the procedure for linking the patient records, the patient name will be discarded. Thus, it will not be possible to link an individual patient to the study data.
The following information will be recorded: age, pregnancy status, number of pulpal abscesses, number of sites of periodontitis (pocket depth ≥ 4 mm), race, highest level of education, DMFT (decayed, missing, filled teeth), number of children, past pregnancy outcomes, diagnosis of diabetes mellitus, and any other known pregnancy related conditions experienced during previous pregnancies from the records of the Dental/Emergent Dental Care Clinic. We will define adverse pregnancy outcomes as gestational diabetes, preeclampsia, pre-term birth, and a low-birthweight infant from the UMC hospital records.
D. Statistical Analysis of data. The data will be analyzed using SPSS v12 using appropriate statistical tests, including factorial ANOVA with post hoc tests, multivariate logistic regression, the Spearman correlation test, and chi square analysis.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Mississippi
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Jackson, Mississippi, United States, 39202
- University of Mississippi Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Female
- Child bearing age or above
Exclusion Criteria:
- Male
- Very young children (before child-bearing age)
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jennifer L Bain, BS, University of Mississippi Medical Center
- Study Director: Roger Johnson, PhD; DMD, University of Mississippi Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006-0198
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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