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

NCT04350489 | Completed

• 1 other identifier: AP-1720
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (2)

• IL-32 isoforms levels

  the levels of IL-32α, IL-32β, IL-32γ, IL-32δ isoforms in gingival crevicular fluid (GCF) and plasma

  baseline

• IL-32 isoforms levels

  the levels of IL-32α, IL-32β, IL-32γ, IL-32δ isoforms in gingival crevicular fluid (GCF) and plasma

  1st month after treatment

Secondary Outcomes (1)

• correlation

  baseline and 1st month after treatment

Study Arms (2)

Control

Periodontally healthy group

Periodontitis

Patients with periodontitis

Other: Non-surgical periodontal treatment

Interventions

Non-surgical periodontal treatment OTHER

Conventional non-surgical periodontal treatment were performed

Periodontitis

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bulent Ecevit University: lead

Study Sites (1)

Ordu University

Ordu, 52100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 11, 2020
• First Posted: April 17, 2020
• Study Start: October 1, 2017
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: April 20, 2020

Record last verified: 2020-04

Locations

TU (1)