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

NCT ID: NCT03171675

Last Updated: 2017-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-25

Study Completion Date

2015-06-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Periodontitis Preterm Labor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Preterm/Chronic Periodontitis

Included ten female patients who underwent spontaneous preterm birth and were diagnosed with chronic periodontitis upon clinical examination

No interventions assigned to this group

Preterm/Healthy Periodontium

Included ten female patients who underwent spontaneous preterm birth and who had a healthy periodontium upon clinical examination

No interventions assigned to this group

Term/Chronic Periodontitis

Included ten female patients who underwent spontaneous normal term birth and were diagnosed with chronic periodontitis upon clinical examination

No interventions assigned to this group

Term/Healthy Periodontium

Included ten female patients who underwent spontaneous normal term birth and who had a healthy periodontium upon clinical examination (Armitage1999)

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohamed Agoor

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ahmed Y. Gamal, PhD

Role: STUDY_CHAIR

Faculty of Dentistry, Ain Shams University

Olfat G. Shaker, PhD

Role: STUDY_DIRECTOR

Cairo University

Fatma H. Mohamed, PhD

Role: STUDY_DIRECTOR

Faculty of Dentistry, Ain Shams University

Mohamed Agoor, MSc

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Ain Shams University

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 10863370 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 10601939 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

22/01/2014; #33

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Biomarker Study
NCT01148654 COMPLETED