PeriodontitisIRAGPAAOITWNCT01812083
Interleukin-1 Receptor Antagonist Gene Polymorphism and Adverse Pregnancy Outcome in Turkish Women
An observational study of Periodontitis, run by Selcuk University.
Trial summary
The investigators hypothesized that the IL-1A (+4895), IL-1B (+3954), and IL-1RN gene polymorphisms may be associated with PLBW. Smoking has been well documented by numerous studies as a major environmental risk factor for periodontitis and adverse pregnancy outcomes. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- How many people
- 156 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Feb 2005
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women between 18-35 years of age with single gestation and with ≥20 on-crowded teeth excluding third molars were included in this study. Subjects were divided into normal birth (NB) and PLBW groups on the basis of their pregnancy outcome. Women who delivered an infant with a birth weight of more than 2500 g after 37 weeks of gestation were placed in the NB group. Women who delivered infants whose birth weight was below 2500 g or before 37 weeks of gestation were placed in the PLBW group.
Who may be able to join
- Subjects were divided into normal birth (NB) and PLBW groups on the basis of their pregnancy outcome. Women who delivered an infant with a birth weight of more than 2500 g after 37 weeks of gestation were placed in the NB group.
Who cannot join
- Current/past tobacco user, alcohol abuse, history of high-risk gestation, hypertension, gestational diabetes, any systemic disease and placenta previa were the exclusion criteria for this study.
About this study
The investigators hypothesized that the IL-1A (+4895), IL-1B (+3954), and IL-1RN gene polymorphisms may be associated with PLBW. Smoking has been well documented by numerous studies as a major environmental risk factor for periodontitis and adverse pregnancy outcomes. Therefore, the investigators only selected non-smoking individuals in this study as the smoking-related risk could obscure the polymorphism-related increase in risk for periodontitis and adverse pregnancy outcomes. This study aimed to determine the association between IL-1A (+4895), IL-1B (+3954), and IL-1RN polymorphisms with adverse pregnancy outcomes and periodontitis in a non-smoking Turkish population.
Read the detailed description
Pregnant women between 18-35 years of age with single gestation and with ≥20 on-crowded teeth excluding third molars were included in this study. Subjects were divided into normal birth (NB) and PLBW groups on the basis of their pregnancy outcome. Women who delivered an infant with a birth weight of more than 2500 g after 37 weeks of gestation were placed in the NB group. Women who delivered infants whose birth weight was below 2500 g or before 37 weeks of gestation were placed in the PLBW group. Current/past tobacco user, alcohol abuse, history of high-risk gestation, hypertension, gestational diabetes, any systemic disease and placenta previa were the exclusion criteria for this study. Maternal, obstetric, and demographic factors such as maternal age, maternal education, regular prenatal care, genitourinary tract infections during pregnancy, total number of births, previous PLBW, and antibiotic use during the pregnancy period were also recorded.
- Conditions
- Periodontitis
- Keywords
- Periodontitis; adverse pregnancy outcomes; IL-1 polymorphism
- Medical subject headings
- Periodontitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-1 receptor antagonist gene polymorphism and adverse pregnancy outcome in Turkish women
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2013 (estimated)
- Study startJan 2004
- Primary completionJun 2004
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilgün Özlem Alptekin, Selcuk University
- Investigators
- Nilgün Özlem Alptekin, DDS,PhD,Prof, Study chair, Selcuk University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812083
- Sponsor's protocol ID
- SelcukU
- Other IDs
- SUDHF1451
- Acronym
- IRAGPAAOITW
- Status last verified
- Mar 2013
- First submitted
- 13 Mar 2013
- Last updated
- 15 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interleukin-1 Receptor Antagonist Gene Polymorphism and Adverse Pregnancy Outcome in Turkish Women
- ClinicalTrials.gov ID
- NCT01812083
- Acronym / sponsor ID
- IRAGPAAOITW / SelcukU
- Conditions
- Periodontitis
- Keywords
- Periodontitis; adverse pregnancy outcomes; IL-1 polymorphism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Jun 2004 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 15 Mar 2013 (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.
The investigators hypothesized that the IL-1A (+4895), IL-1B (+3954), and IL-1RN gene polymorphisms may be associated with PLBW. Smoking has been well documented by numerous studies as a major environmental risk factor for periodontitis and adverse pregnancy outcomes. Therefore, the investigators only selected non-smoking individuals in this study as the smoking-related risk could obscure the polymorphism-related increase in risk for periodontitis and adverse pregnancy outcomes. This study aimed to determine the association between IL-1A (+4895), IL-1B (+3954), and IL-1RN polymorphisms with adverse pregnancy outcomes and periodontitis in a non-smoking Turkish population.
Detailed description
Pregnant women between 18-35 years of age with single gestation and with ≥20 on-crowded teeth excluding third molars were included in this study. Subjects were divided into normal birth (NB) and PLBW groups on the basis of their pregnancy outcome. Women who delivered an infant with a birth weight of more than 2500 g after 37 weeks of gestation were placed in the NB group. Women who delivered infants whose birth weight was below 2500 g or before 37 weeks of gestation were placed in the PLBW group. Current/past tobacco user, alcohol abuse, history of high-risk gestation, hypertension, gestational diabetes, any systemic disease and placenta previa were the exclusion criteria for this study. Maternal, obstetric, and demographic factors such as maternal age, maternal education, regular prenatal care, genitourinary tract infections during pregnancy, total number of births, previous PLBW, and antibiotic use during the pregnancy period were also recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women between 18-35 years of age with single gestation and with ≥20 on-crowded teeth excluding third molars were included in this study. Subjects were divided into normal birth (NB) and PLBW groups on the basis of their pregnancy outcome. Women who delivered an infant with a birth weight of more than 2500 g after 37 weeks of gestation were placed in the NB group. Women who delivered infants whose birth weight was below 2500 g or before 37 weeks of gestation were placed in the PLBW group.
Key inclusion criteria (1 listed)
- Subjects were divided into normal birth (NB) and PLBW groups on the basis of their pregnancy outcome. Women who delivered an infant with a birth weight of more than 2500 g after 37 weeks of gestation were placed in the NB group.
Key exclusion criteria (1 listed)
- Current/past tobacco user, alcohol abuse, history of high-risk gestation, hypertension, gestational diabetes, any systemic disease and placenta previa were the exclusion criteria for this study.
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
Interleukin-1 receptor antagonist gene polymorphism and adverse pregnancy outcome in Turkish women
Time frame: 5 months
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 15 Mar 2013.
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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.
Nilgün Özlem Alptekin, DDS,PhD,Prof study chair
Selcuk University Faculty of Dentistry
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis, run by Selcuk University.
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 1 inclusion and 1 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 15 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Interleukin-1 receptor antagonist gene polymorphism and adverse pregnancy outcome in Turkish women (time frame: 5 months). 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 15 Mar 2013.