Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00490165
Status:
COMPLETED
Last Update Posted:
2012-04-06
First Post:
2007-06-20
Brief Title:
Periodontal and Periapical Inflammation and Pregnancy
Sponsor:
Roger Johnson
Organization:
University of Mississippi Medical Center
Study Overview
Official Title:
Associations Between Periodontal and Periapical Inflammation and Pregnancy Outcomes
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
A Specific Aims
1 To determine possible associations between periapical oral infection and adverse pregnancy outcomes in female patients in the School of Dentistry the DentalDental Emergent Care Clinic Jackson Medical Mall and the UMC Hospital
2 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 DentalDental 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 DentalEmergent 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
1 To determine possible associations between periapical oral infection and adverse pregnancy outcomes in female patients in the School of Dentistry the DentalDental Emergent Care Clinic Jackson Medical Mall and the UMC Hospital
2 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 DentalDental 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 DentalEmergent 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None