Clinical trial NCT03171675: Gingival Crevicular Fluid and Placental Tissue Levels of Interleukin-17 as a Possible Marker for Preterm Labor in Patients With Chronic Periodontitis
Official title: Gingival Crevicular Fluid and Placental Tissue Levels of Interleukin-17 as a Possible Marker for Preterm Labor in Patients With Chronic Periodontitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-05-31
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Interleukin-17
timeFrame: Single sample from each patient following birth
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Faculty of Dentistry, Ain Shams University
name: Ahmed Y. Gamal, PhD
role: STUDY_CHAIR
affiliation: Cairo University
name: Olfat G. Shaker, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Dentistry, Ain Shams University
name: Fatma H. Mohamed, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Dentistry, Ain Shams University
name: Mohamed Agoor, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.