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Completed

NCT Number: NCT04350489

IL-32 Isoforms Levels in GCF 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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ordu University

Ordu, 52100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-surgical periodontal treatment

Other

Conventional non-surgical periodontal treatment were performed

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Bulent Ecevit University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 17, 2020
Registry last updated
Apr 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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