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

NCT03171675 | Completed

• 1 other identifier: 22/01/2014; #33
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• Interleukin-17

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

  Single sample from each patient following birth

Study Arms (4)

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)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (3)

• 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.

  PMID: 10863370 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 10601939 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Gingival crevicular fluid and placental tissue samples

MeSH Terms

Conditions

Chronic Periodontitis; Obstetric Labor, Premature; Premature Birth; Periodontal Diseases; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Ahmed Y. Gamal, PhD

  Faculty of Dentistry, Ain Shams University

  STUDY CHAIR

• Olfat G. Shaker, PhD

  Cairo University

  STUDY DIRECTOR

• Fatma H. Mohamed, PhD

  Faculty of Dentistry, Ain Shams University

  STUDY DIRECTOR

• Mohamed Agoor, MSc

  Faculty of Dentistry, Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 28, 2017
• First Posted: May 31, 2017
• Study Start: December 25, 2014
• Primary Completion: March 2, 2015
• Study Completion: June 16, 2015
• Last Updated: July 24, 2017

Record last verified: 2017-07