IL-32 Isoforms Levels in GCF and Plasma of the Patients With Periodontitis

April 16, 2020 updated by: Figen Öngöz Dede, Bulent Ecevit University

Increased Levels of Interleukin-32 Isoforms Alpha, Beta, Gamma, and Delta in the Gingival Crevicular Fluid and Plasma of the Patients With Periodontitis

Interleukin (IL)-32, which has been recently reported to be associated with periodontitis, has been suggested to have pleiotropic effect due to its 9 different isoforms. The aim of this study was to investigate the levels of IL-32α, IL-32β, IL-32γ, IL-32δ isoforms in gingival crevicular fluid (GCF) and plasma before and after nonsurgical periodontal treatment in patients with periodontitis (P).Twenty-seven P and 27 periodontally healthy controls (C) were recruited in this study. Periodontitis patients were performed nonsurgical periodontal treatment. GCF and plasma sampling and clinical periodontal parameters were evaluated before and 1 month after treatment. Enzyme-linked immunosorbent assay was used to analyze the levels of IL-32α, IL-32β, IL-32γ, IL-32δ isoforms in GCF and plasma samples.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ordu, Turkey, 52100
        • Ordu University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

  1. group (Control): Periodontally and systemically healthy
  2. group: Systemically healthy and periodontitis

Description

Inclusion Criteria:

  • Have at least 20 natural teeth, excluding third molars.
  • Periodontitis patients had at least two non-adjacent sites per quadrant with probing depth (PD) ≥ 5 mm and clinical attachment level (CAL) ≥ 5 mm with gingival inflammation, and alveolar bone loss affecting >30% of the teeth, as detected on clinical and radiographical examinations.
  • Periodontally healthy control group had no sign of gingival inflammation, no PD > 3mm and no evidence of attachment or bone loss

Exclusion Criteria:

  • History of systemic disease.
  • Regular use of any drugs which can effect the immune system or inflammatory response in the 6 months preceding the start of the study.
  • Periodontal treatment during last 6 months that could affect periodontal status.
  • Smoking.
  • History of radiotherapy or chemotherapy.
  • Current pregnancy, lactation or menopause.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Periodontitis
Patients with periodontitis
Other: Non-surgical periodontal treatment
Conventional non-surgical periodontal treatment were performed
Control
Periodontally healthy group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IL-32 isoforms levels
Time Frame: baseline
the levels of IL-32α, IL-32β, IL-32γ, IL-32δ isoforms in gingival crevicular fluid (GCF) and plasma
baseline
IL-32 isoforms levels
Time Frame: 1st month after treatment
the levels of IL-32α, IL-32β, IL-32γ, IL-32δ isoforms in gingival crevicular fluid (GCF) and plasma
1st month after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation
Time Frame: baseline and 1st month after treatment
the levels of IL-32α, IL-32β, IL-32γ, IL-32δ isoforms in gingival crevicular fluid (GCF) and plasma and clinical parameters
baseline and 1st month after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bulent Ecevit University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2017

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

April 11, 2020

First Submitted That Met QC Criteria

April 14, 2020

First Posted (Actual)

April 17, 2020

Study Record Updates

Last Update Posted (Actual)

April 20, 2020

Last Update Submitted That Met QC Criteria

April 16, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AP-1720

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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