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.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis; Preterm Labor

• Study Type: Observational
• Enrollment (Actual): 40

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interleukin-17	Interleukin-17 levels in gingival crevicular fluid and placental tissue samples	Single sample from each patient following birth

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: 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 and helpful links

General 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.
• Glick 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 25, 2014
• Primary Completion (Actual): March 2, 2015
• Study Completion (Actual): June 16, 2015

Study Registration Dates

• First Submitted: May 28, 2017
• First Submitted That Met QC Criteria: May 28, 2017
• First Posted (Actual): May 31, 2017

Study Record Updates

• Last Update Posted (Actual): July 24, 2017
• Last Update Submitted That Met QC Criteria: July 20, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Periodontitis; Preterm Birth; IL-17; Periodontal Disease; Interleukin-17; Chronic Periodontitis; Preterm Labor; Periodontal risk factors; Medical risk factors
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Pregnancy Complications; Obstetric Labor Complications; Periodontitis; Premature Birth; Chronic Periodontitis; Obstetric Labor, Premature
• Other Study ID Numbers: 22/01/2014; #33

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No