Chronic PeriodontitisNCT03171675
Gingival Crevicular Fluid and Placental Tissue Levels of Interleukin-17 as a Possible Marker for Preterm Labor in Patients With Chronic Periodontitis
An observational study of Chronic Periodontitis and Preterm Labor, run by Ain Shams University.
Trial summary
This case control-study measures the levels of Interleukin-17 in gingival crevicular fluid and placental tissue samples of pregnant females as a possible marker in determining whether or not an association exists between chronic periodontitis and preterm labor. 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
- Chronic Periodontitis, Preterm Labor
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 25 Dec 2014to 16 Jun 2015
- 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: Conducted in Cairo, Egypt at the Maternal-Fetal Medical Clinic at the Department of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University.
Who may be able to join
- Within the age range of 18-35 years
- Free of any systemic diseases as referenced from Burket's Oral Medicine health history questionnaire (Glick2008)
- Spontaneous normal term birth at ≥37 weeks of gestation without any obstetrical or medical complications
- Spontaneous preterm birth (PTB) at <37 weeks of gestation after uterine contraction or rupture of membranes (Keelan1999)
Who cannot join
- History of medications that may affect the study outcome, such as: current use of systemic corticosteroids or antibiotics for at least one month
- Genital and urinary tract infections
- Existing hypertension and diabetes mellitus before pregnancy, autoimmune disease, asthma, and chronic renal disease
- Multiple pregnancies, cervical cerculage, abnormal placentation, past history of preterm delivery, or antepartum hemorrhage
- Low or high maternal body mass index
About this study
This case control-study measures the levels of Interleukin-17 in gingival crevicular fluid and placental tissue samples of pregnant females as a possible marker in determining whether or not an association exists between chronic periodontitis and preterm labor. Interleukin-17 is a pro-inflammatory cytokine whose levels have been proven to increase in periodontal disease.
- Conditions
- Chronic Periodontitis, Preterm Labor
- Keywords
- Chronic Periodontitis, Preterm Labor, Preterm Birth, Interleukin-17, IL-17, Periodontal Disease, Periodontitis, Periodontal risk factors, Medical risk factors
- Medical subject headings
- Chronic Periodontitis, Obstetric Labor, Premature, Premature Birth, Periodontal Diseases, Periodontitis
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 |
|---|---|---|
| Preterm/Chronic Periodontitis | Included ten female patients who underwent spontaneous preterm birth and were diagnosed with chronic periodontitis upon clinical examination | |
| Preterm/Healthy Periodontium | Included ten female patients who underwent spontaneous preterm birth and who had a healthy periodontium upon clinical examination | |
| Term/Chronic Periodontitis | Included ten female patients who underwent spontaneous normal term birth and were diagnosed with chronic periodontitis upon clinical examination | |
| Term/Healthy Periodontium | Included ten female patients who underwent spontaneous normal term birth and who had a healthy periodontium upon clinical examination (Armitage1999) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-17
Interleukin-17 levels in gingival crevicular fluid and placental tissue samples
Measured: Single sample from each patient following birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start25 Dec 2014
- Primary completion2 Mar 2015
- Study completion16 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Agoor, Ain Shams University
- Investigators
- Ahmed Y. Gamal, PhD, Study chair, Faculty of Dentistry, Ain Shams UniversityOlfat G. Shaker, PhD, Study director, Cairo UniversityFatma H. Mohamed, PhD, Study director, Faculty of Dentistry, Ain Shams UniversityMohamed Agoor, MSc, Principal investigator, Faculty of Dentistry, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171675
- Sponsor's protocol ID
- 22/01/2014; #33
- Status last verified
- Jul 2017
- First submitted
- 28 May 2017
- Last updated
- 24 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Armitage GC. Development of a classification system for periodontal diseases and conditions. Ann Periodontol. 1999 Dec;4(1):1-6. doi: 10.1902/annals.1999.4.1.1.
PubMed 10863370Glick M, Greenberg MS, Ship JA. Introduction to oral medicine and oral diagnosis: evaluation of the dental patient. In: Greenberg MS, Glick M, Ship JA. Burket's Oral Medicine. 11th Edition. Hamilton, Ontario: BC Decker; 2008:3.
Keelan JA, Marvin KW, Sato TA, Coleman M, McCowan LM, Mitchell MD. Cytokine abundance in placental tissues: evidence of inflammatory activation in gestational membranes with term and preterm parturition. Am J Obstet Gynecol. 1999 Dec;181(6):1530-6. doi: 10.1016/s0002-9378(99)70400-x.
PubMed 10601939
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gingival Crevicular Fluid and Placental Tissue Levels of Interleukin-17 as a Possible Marker for Preterm Labor in Patients With Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT03171675
- Acronym / sponsor ID
- 22/01/2014; #33
- Conditions
- Chronic Periodontitis, Preterm Labor
- Keywords
- Chronic Periodontitis, Preterm Labor, Preterm Birth, Interleukin-17, IL-17, Periodontal Disease, Periodontitis, Periodontal risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 25 Dec 2014 (actual)
- Primary completion
- 2 Mar 2015 (actual)
- Study completion
- 16 Jun 2015 (actual)
- First posted
- 31 May 2017 (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.
This case control-study measures the levels of Interleukin-17 in gingival crevicular fluid and placental tissue samples of pregnant females as a possible marker in determining whether or not an association exists between chronic periodontitis and preterm labor. Interleukin-17 is a pro-inflammatory cytokine whose levels have been proven to increase in periodontal disease.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Preterm/Chronic Periodontitis | – | –Included ten female patients who underwent spontaneous preterm birth and were diagnosed with chronic periodontitis upon clinical examination |
| Preterm/Healthy Periodontium | – | –Included ten female patients who underwent spontaneous preterm birth and who had a healthy periodontium upon clinical examination |
| Term/Chronic Periodontitis | – | –Included ten female patients who underwent spontaneous normal term birth and were diagnosed with chronic periodontitis upon clinical examination |
| Term/Healthy Periodontium | – | –Included ten female patients who underwent spontaneous normal term birth and who had a healthy periodontium upon clinical examination (Armitage1999) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Conducted in Cairo, Egypt at the Maternal-Fetal Medical Clinic at the Department of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University.
Key inclusion criteria (4 listed)
- Within the age range of 18-35 years
- Free of any systemic diseases as referenced from Burket's Oral Medicine health history questionnaire (Glick2008)
- Spontaneous normal term birth at ≥37 weeks of gestation without any obstetrical or medical complications
- Spontaneous preterm birth (PTB) at <37 weeks of gestation after uterine contraction or rupture of membranes (Keelan1999)
Key exclusion criteria (5 listed)
- History of medications that may affect the study outcome, such as: current use of systemic corticosteroids or antibiotics for at least one month
- Genital and urinary tract infections
- Existing hypertension and diabetes mellitus before pregnancy, autoimmune disease, asthma, and chronic renal disease
- Multiple pregnancies, cervical cerculage, abnormal placentation, past history of preterm delivery, or antepartum hemorrhage
- Low or high maternal body mass index
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-17
Time frame: Single sample from each patient following birth
Interleukin-17 levels in gingival crevicular fluid and placental tissue samples
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 24 Jul 2017.
- Background: PubMed 10863370Armitage GC. Development of a classification system for periodontal diseases and conditions. Ann Periodontol. 1999 Dec;4(1):1-6. doi: 10.1902/annals.1999.4.1.1.
- BackgroundGlick M, Greenberg MS, Ship JA. Introduction to oral medicine and oral diagnosis: evaluation of the dental patient. In: Greenberg MS, Glick M, Ship JA. Burket's Oral Medicine. 11th Edition. Hamilton, Ontario: BC Decker; 2008:3.
- Background: PubMed 10601939Keelan JA, Marvin KW, Sato TA, Coleman M, McCowan LM, Mitchell MD. Cytokine abundance in placental tissues: evidence of inflammatory activation in gestational membranes with term and preterm parturition. Am J Obstet Gynecol. 1999 Dec;181(6):1530-6. doi: 10.1016/s0002-9378(99)70400-x.
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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.
Ahmed Y. Gamal, PhD study chair
Faculty of Dentistry, Ain Shams University
Olfat G. Shaker, PhD study director
Cairo University
Fatma H. Mohamed, PhD study director
Faculty of Dentistry, Ain Shams University
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Periodontitis and Preterm Labor, run by Ain Shams 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 4 inclusion and 5 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 24 Jul 2017. 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-17 (time frame: Single sample from each patient following birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03171675, which also lists 3 linked publications.
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 24 Jul 2017.