Inflammatory Cytokines in GCF and Placental Tissues in Chronic Periodontitis Patients With Preterm Delivery

NCT02521688 | Completed DMC

• 1 other identifier: FDASU-RECD 1214402
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Investigators have shown the presence of elevated proinflammatory cytokines in amniotic fluid in patients in preterm labor.However, there is limited and mostly negative evidence that the elevation of these mediators in gingival crevicular fluid (GCF), and amniotic fluid are associated with pregnancy complications in periodontitis patients. Thus this case control study will be conducted to

1. 1.To determine the level of proinflammatory cytokines in gingival crevicular fluid in women with spontaneous preterm delivery with chronic periodontitis.
2. 2.To investigate the expression of macrophage inflammatory protein-1α in placental tissues.
3. 3.To assess the possible correlation between chronic periodontitis and preterm delivery.

Conditions

Preterm Labor; Periodontitis

Outcome Measures

Primary Outcomes (1)

• Proinflammatory cytokine level

  MIP, TNF, Pentrixin 3 measured in placental tissue homogenate and in GCF

  1 year

Study Arms (4)

Group I (PTD + CP)

include ten mothers exhibiting spontaneous preterm delivery with moderate to severe chronic periodontitis +incisional biopsy from placenta and GCF sample

Procedure: incisional biopsy from placenta and GCF sample

Group II (TD + CP)

include ten mothers exhibiting spontaneous term delivery with moderate to severe chronic periodontitis+incisional biopsy from placenta and GCF sample

Procedure: incisional biopsy from placenta and GCF sample

Group III (PTD + HP)

include tenmothersexhibiting spontaneous preterm delivery with healthy periodontium +incisional biopsy from placenta and GCF sample

Procedure: incisional biopsy from placenta and GCF sample

Group IV (TD + HP)

ten mothersexhibiting spontaneous term delivery with healthy periodontium(Armitage GC. 1999)+ incisional biopsy from placenta and GCF sample

Procedure: incisional biopsy from placenta and GCF sample

Interventions

incisional biopsy from placenta and GCF sample PROCEDURE

A small piece of villous placental tissue (approximately 1 cm3) will be dissected free of maternal decidua from the placental bed after delivery of fetus processed to prepare tissue homogenate according to the standardized technique (Keelan JA, et al. 1999) GCF will be obtained from each patient by filter paper inserted in gingival crevice for few seconds after isolation by cotton.

Group I (PTD + CP); Group II (TD + CP); Group III (PTD + HP); Group IV (TD + HP)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Fourty Mothers participating in this study recruited from Maternal-Fetal medicine clinic, Faculty of Medicine, Ain Shams University that must undergo delivery without induction, i.e. delivery following labour pains not pre-scheduled caesarian sections

You may qualify if:

• Undergoing spontaneous term delivery (TD) at ≥37 weeks of gestation without any obstetrical or medical complications or spontaneous preterm delivery (PTD)at\< 37 weeks of gestation after uterine contraction or rupture of membranes(Keelan JA, et al. 1999).
• With a body mass index (BMI) ranged from 19-25.
• Having no systemic disease as evidenced by Burkett's oral medicine health history questionnaire (Glick et al, 2008).

You may not qualify if:

• Mothers receiving antibiotics or corticosteroids during last three months of pregnancy or at delivery.
• Current Smokers and drug abusers or stopped from period shorter than 6 months.
• Mothers with urinary tract infection, vulvovaginal infection, previous preterm birth, or any othermedical disorder associated with pregnancy as obtained from patient's record.

Sponsors & Collaborators

• Ain Shams University: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Placental tissue Gingival clevicular fluid from deepest pocket

MeSH Terms

Conditions

Obstetric Labor, Premature; Periodontitis

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of oral medicine and periodontology

Study Record Dates

• First Submitted: August 11, 2015
• First Posted: August 13, 2015
• Study Start: August 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 13, 2015

Record last verified: 2015-08