Periodontal DiseaseNCT00582374
Periodontal Disease and Preterm Birth
An observational study of Periodontal Disease and Preterm Birth, run by University of Oklahoma at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease, Preterm Birth, Low Birth Weight
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Mar 2009
- 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 15 to 35 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Pregnant women from the OU Medical Center Women's Clinic
Who may be able to join
- Between the ages of 15-35
- Singleton gestation
Who cannot join
- Diabetes prior to pregnancy
- Require antibiotic prophylaxis prior to dental treatment
- Require steroids during pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: 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.
Read the 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.
- Conditions
- Periodontal Disease, Preterm Birth, Low Birth Weight
- Keywords
- Periodontal Disease, Preterm Birth, Low Birth Weight, Pregnancy
- Medical subject headings
- Periodontal Diseases, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | Pregnant Women |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Secondary outcomes (1)
To determine whether IL-1β levels in the oral cavity and the vagina are associated with preterm birth or low-birth weight.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study startMar 2005
- Primary completionMar 2009 (estimated)
- Study completionMar 2009 (estimated)
Why it stopped: PI passed away unexpectedly
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.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Knudtson, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00582374
- Sponsor's protocol ID
- PeriodontalPreTermBirth
- Status last verified
- Mar 2017
- First submitted
- 19 Dec 2007
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Disease, Inflammatory Markers, and Preterm Birth
- ClinicalTrials.gov ID
- NCT00582374
- Acronym / sponsor ID
- PeriodontalPreTermBirth
- Conditions
- Periodontal Disease, Preterm Birth, Low Birth Weight
- Keywords
- Periodontal Disease, Preterm Birth, Low Birth Weight, Pregnancy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI passed away unexpectedly
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Mar 2009 (estimated)
- Study completion
- Mar 2009 (estimated)
- First posted
- 28 Dec 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | –Pregnant Women |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Pregnant women from the OU Medical Center Women's Clinic
Key inclusion criteria (2 listed)
- Between the ages of 15-35
- Singleton gestation
Key exclusion criteria (3 listed)
- Diabetes prior to pregnancy
- Require antibiotic prophylaxis prior to dental treatment
- Require steroids during pregnancy
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
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.
Time frame: 4 years
1 secondary outcome
To determine whether IL-1β levels in the oral cavity and the vagina are associated with preterm birth or low-birth weight.
Time frame: 4 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
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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.
Eric Knudtson, MD principal investigator
University of Oklahoma
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 Preterm Birth, run by University of Oklahoma 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 3 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: withdrawn, as of the sponsor's last update on 28 Mar 2017. 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 was withdrawn before enrolling participants, so there are no results.
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.
What does the primary outcome measure?
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. (time frame: 4 years). It is what the study was designed to measure, not a finding.
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 28 Mar 2017.