PregnancyNCT03449186
Th17 Inducing Cytokines Pregnancy and After Postpartum
An observational study of Pregnancy, run by Aydin Adnan Menderes University.
Trial summary
The aim of this study was to investigate salivary and gingival crevicular fluid (GCF) levels of IL-17A, IL-17E, IL-6 AND IL-23 during 2/3 trimester of pregnancy and after delivery. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Saliva collection and GCF collection
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2013to Jan 2018
- How long will I take part?
- 9 Months
- 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 19 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: All participants had 20 teeth present at least.
Who may be able to join
- women 2 and 3 trimester of their pregnancy
Who cannot join
- any known systemic disease,
- periodontal treatment within the last six months,
- patients having less than 10 teeth,
- smokers,
- individuals with a BMI > 30 kg/m2,
- gestational diabetes and preeclampsia during pregnancy.
About this study
Official title: Interleukin-17 and Th17 Inducing Cytokines Exacerbate Periodontal Disease During Pregnancy and Postpartum
The aim of this study was to investigate salivary and gingival crevicular fluid (GCF) levels of IL-17A, IL-17E, IL-6 AND IL-23 during 2/3 trimester of pregnancy and after delivery.
Read the detailed description
IL-17 have a synergytic effect with IL-6 and IL-23. IL-17A levels elevated with periodontal diseases. Many systemical chronic conditions such as atherosclerosis and cardiovascular disease, pregnancy may contribute increasing of IL-17 family cytokine.
- Conditions
- Pregnancy
- Being tested
- Saliva collection, GCF collection
- Keywords
- periodontitis, postpartum
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva collectionOther
GCF collectionOther
| Study group | Role | What they receive |
|---|---|---|
| Pregnancy group | Women, who were in their second trimester (weeks 16-24) or third trimester (weeks 25-34)selected for the study. Saliva and GCF samples were collected and clinical periodontal measurements were made gently Receives: Other: Saliva collection; Other: GCF collection | |
| Postpartum group | Postpartum women 6 months after giving birth recalled. Saliva and GCF samples were collected and clinical periodontal measurements were made. Receives: Other: Saliva collection; Other: GCF collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changing Il-17A levels
Salivary and GCF level measured by ELISA
Measured: 6 month
Secondary outcomes (3)
Changing IL-6 levels
Salivary and GCF level measured by ELISA
Measured: 6 month
Changing IL-23 levels
Salivary and GCF level measured by ELISA
Measured: 6 month
Changing IL-17E levels
Salivary and GCF level measured by ELISA
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start1 Apr 2013
- Primary completionApr 2014
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes 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
- Prospective
- Enrolment
- 114 participants (actual)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veli Özgen Öztürk, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449186
- Sponsor's protocol ID
- BAP-2015
- Status last verified
- Feb 2018
- First submitted
- 26 Jan 2018
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interleukin-17 and Th17 Inducing Cytokines Exacerbate Periodontal Disease During Pregnancy and Postpartum
- ClinicalTrials.gov ID
- NCT03449186
- Acronym / sponsor ID
- BAP-2015
- Conditions
- Pregnancy
- Keywords
- periodontitis, postpartum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 28 Feb 2018 (actual)
- 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 aim of this study was to investigate salivary and gingival crevicular fluid (GCF) levels of IL-17A, IL-17E, IL-6 AND IL-23 during 2/3 trimester of pregnancy and after delivery.
Detailed description
IL-17 have a synergytic effect with IL-6 and IL-23. IL-17A levels elevated with periodontal diseases. Many systemical chronic conditions such as atherosclerosis and cardiovascular disease, pregnancy may contribute increasing of IL-17 family cytokine.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnancy group | – | Other: Saliva collection, Other: GCF collectionWomen, who were in their second trimester (weeks 16-24) or third trimester (weeks 25-34)selected for the study. Saliva and GCF samples were collected and clinical periodontal measurements were made gently |
| Postpartum group | – | Other: Saliva collection, Other: GCF collectionPostpartum women 6 months after giving birth recalled. Saliva and GCF samples were collected and clinical periodontal measurements were made. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All participants had 20 teeth present at least.
Key inclusion criteria (1 listed)
- women 2 and 3 trimester of their pregnancy
Key exclusion criteria (6 listed)
- any known systemic disease,
- periodontal treatment within the last six months,
- patients having less than 10 teeth,
- smokers,
- individuals with a BMI > 30 kg/m2,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saliva collection | Other | Postpartum group, Pregnancy group |
| GCF collection | Other | Postpartum group, Pregnancy group |
Primary outcome
Changing Il-17A levels
Time frame: 6 month
Salivary and GCF level measured by ELISA
3 secondary outcomes
Changing IL-6 levels
Time frame: 6 month
Changing IL-23 levels
Time frame: 6 month
Changing IL-17E levels
Time frame: 6 month
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 28 Feb 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Aydin Adnan Menderes 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 6 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 28 Feb 2018. 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?
Changing Il-17A levels (time frame: 6 month). 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 Feb 2018.