NCT00490165

Brief Summary

This is a retrospective chart review of patient records at the University of Mississippi Medical Center. We are not actively recruiting patients for this study. Recent animal studies we conducted showed that periapical abscesses during pregnancy cause a systemic inflammatory response in the mother. Also due to the increase in TNF-alpha (an inflammatory cytokine) the mother also become insulin resistant and thus developed gestational diabetes. Periodontal inflammation has been shown in the research to lead to low-birth weight and pre-term birth. We are looking retrospectively to see if an association exists in charted data between periapical and periodontal inflammation and adverse pregnancy outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2007

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

April 6, 2012

Status Verified

April 1, 2012

Enrollment Period

4.8 years

First QC Date

June 20, 2007

Last Update Submit

April 5, 2012

Conditions

Eligibility Criteria

Age10 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We are looking at charts of patients (former patients) at the University of Mississippi School of Dentistry. Since this is a pregnancy study we are looking only at the charts of female patients. The youngest record we review is 10 and there is no upper limit to the age.

You may qualify if:

  • Female
  • Child bearing age or above

You may not qualify if:

  • Male
  • Very young children (before child-bearing age)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39202, United States

Location

MeSH Terms

Conditions

Periodontal DiseasesPeriapical DiseasesDiabetes MellitusCardiovascular DiseasesDental Caries

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesJaw DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesTooth DemineralizationTooth Diseases

Study Officials

  • Jennifer L Bain, BS

    University of Mississippi Medical Center

    PRINCIPAL INVESTIGATOR
  • Roger Johnson, PhD; DMD

    University of Mississippi Medical Center

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 20, 2007

First Posted

June 22, 2007

Study Start

March 1, 2007

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

April 6, 2012

Record last verified: 2012-04

Locations