Periodontal DiseaseNCT00490165
Periodontal and Periapical Inflammation and Pregnancy
An observational study of Periodontal Disease and Periapical Disease, run by Roger Johnson at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease, Periapical Disease, Pregnancy
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Female
- Child bearing age or above
Who cannot join
- Male
- Very young children (before child-bearing age)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39202
About this study
Official title: Associations Between Periodontal and Periapical Inflammation and Pregnancy Outcomes
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.
Read the detailed description
- 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.
- 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).
- 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.
- 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.
- Conditions
- Periodontal Disease, Periapical Disease, Pregnancy, Diabetes, Cardiovascular Disease, Dental Caries
- Medical subject headings
- Periodontal Diseases, Periapical Diseases, Diabetes Mellitus, Cardiovascular Diseases, Dental Caries
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2007 (estimated)
- Study startMar 2007
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roger Johnson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Roger Johnson, University of Mississippi Medical Center
- Investigators
- Jennifer L Bain, BS, Principal investigator, University of Mississippi Medical CenterRoger Johnson, PhD; DMD, Study director, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00490165
- Sponsor's protocol ID
- 2006-0198
- Status last verified
- Apr 2012
- First submitted
- 20 Jun 2007
- Last updated
- 6 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations Between Periodontal and Periapical Inflammation and Pregnancy Outcomes
- ClinicalTrials.gov ID
- NCT00490165
- Acronym / sponsor ID
- 2006-0198
- Conditions
- Periodontal Disease, Periapical Disease, Pregnancy, Diabetes, Cardiovascular Disease, Dental Caries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Roger JohnsonUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 22 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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).
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 10 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Female
- Child bearing age or above
Key exclusion criteria (2 listed)
- Male
- Very young children (before child-bearing age)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer L Bain, BS principal investigator
University of Mississippi Medical Center
Roger Johnson, PhD; DMD study director
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Disease and Periapical Disease, run by Roger Johnson at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2012.