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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04350489
• Other study ID #: AP-1720
• Status: Completed
• Start date: October 1, 2017
• Est. completion date: May 1, 2019

Study information

• Verified date: April 2020
• Source: Bulent Ecevit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontitis

Intervention

Other:
• Non-surgical periodontal treatment
Conventional non-surgical periodontal treatment were performed

Locations

Country	Name	City	State
Turkey	Ordu University	Ordu

Sponsors (1)

Lead Sponsor	Collaborator
Bulent Ecevit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IL-32 isoforms levels	the levels of IL-32a, IL-32ß, IL-32?, IL-32d isoforms in gingival crevicular fluid (GCF) and plasma	baseline
Primary	IL-32 isoforms levels	the levels of IL-32a, IL-32ß, IL-32?, IL-32d isoforms in gingival crevicular fluid (GCF) and plasma	1st month after treatment
Secondary	correlation	the levels of IL-32a, IL-32ß, IL-32?, IL-32d isoforms in gingival crevicular fluid (GCF) and plasma and clinical parameters	baseline and 1st month after treatment