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Gingival Crevicular Fluid and Placental Tissue Levels of Interleukin-17 as a Possible Marker for Preterm Labor in Patients With Chronic Periodontitis

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ClinicalTrials.gov Identifier: NCT03171675
Recruitment Status : Completed
First Posted : May 31, 2017
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):
Mohamed Agoor, Ain Shams University

Brief 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. Interleukin-17 is a pro-inflammatory cytokine whose levels have been proven to increase in periodontal disease.

Condition or disease
Chronic Periodontitis Preterm Labor

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Gingival Crevicular Fluid and Placental Tissue Levels of Interleukin-17 as a Possible Marker for Preterm Labor in Patients With Chronic Periodontitis
Actual Study Start Date : December 25, 2014
Actual Primary Completion Date : March 2, 2015
Actual Study Completion Date : June 16, 2015

Group/Cohort
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)



Primary Outcome Measures :
  1. Interleukin-17 [ Time Frame: Single sample from each patient following birth ]
    Interleukin-17 levels in gingival crevicular fluid and placental tissue samples


Biospecimen Retention:   Samples With DNA
Gingival crevicular fluid and placental tissue samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  1. Within the age range of 18-35 years
  2. Free of any systemic diseases as referenced from Burket's Oral Medicine health history questionnaire (Glick2008)
  3. Spontaneous normal term birth at ≥37 weeks of gestation without any obstetrical or medical complications
  4. Spontaneous preterm birth (PTB) at <37 weeks of gestation after uterine contraction or rupture of membranes (Keelan1999)

Exclusion Criteria:

  1. History of medications that may affect the study outcome, such as: current use of systemic corticosteroids or antibiotics for at least one month
  2. Genital and urinary tract infections
  3. Existing hypertension and diabetes mellitus before pregnancy, autoimmune disease, asthma, and chronic renal disease
  4. Multiple pregnancies, cervical cerculage, abnormal placentation, past history of preterm delivery, or antepartum hemorrhage
  5. Low or high maternal body mass index

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03171675


Sponsors and Collaborators
Ain Shams University
Investigators
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Study Chair: Ahmed Y. Gamal, PhD Faculty of Dentistry, Ain Shams University
Study Director: Olfat G. Shaker, PhD Cairo University
Study Director: Fatma H. Mohamed, PhD Faculty of Dentistry, Ain Shams University
Principal Investigator: Mohamed Agoor, MSc Faculty of Dentistry, Ain Shams University

Publications:
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Responsible Party: Mohamed Agoor, Principal Investigator, Ain Shams University
ClinicalTrials.gov Identifier: NCT03171675     History of Changes
Other Study ID Numbers: 22/01/2014; #33
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mohamed Agoor, Ain Shams University:
Chronic Periodontitis
Preterm Labor
Preterm Birth
Interleukin-17
IL-17
Periodontal Disease
Periodontitis
Periodontal risk factors
Medical risk factors

Additional relevant MeSH terms:
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Premature Birth
Periodontitis
Chronic Periodontitis
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases