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

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03171675
• Other study ID #: 22/01/2014; #33
• Status: Completed
• Phase: N/A
• First received: May 28, 2017
• Last updated: July 20, 2017
• Start date: December 25, 2014
• Est. completion date: June 16, 2015

Study information

• Verified date: July 2017
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 16, 2015
• Est. primary completion date: March 2, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Obstetric Labor, Premature
• Periodontitis
• Premature Birth
• Preterm Labor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

References & Publications (3)

Armitage GC. Development of a classification system for periodontal diseases and conditions. Ann Periodontol. 1999 Dec;4(1):1-6. Review. — View 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.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interleukin-17	Interleukin-17 levels in gingival crevicular fluid and placental tissue samples	Single sample from each patient following birth