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Completed

NCT Number: NCT03171675

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Interleukin-17

    Time frame: Single sample from each patient following birth

    Interleukin-17 levels in gingival crevicular fluid and placental tissue samples

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 31, 2017
Registry last updated
Jul 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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