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

Completed

• Conditions: Chronic Periodontitis; Preterm Labor

• Registration Number: NCT03171675
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-25
• Primary Completion: 2015-03-02
• Study Completion: 2015-06-16
• Study First Submitted: 2017-05-28
• Study First Submitted QC: 2017-05-28
• Study First Posted: 2017-05-31
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-20
• Last Update Posted: 2017-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Interleukin-17	Single sample from each patient following birth	Interleukin-17 levels in gingival crevicular fluid and placental tissue samples