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OpenTrials
Completed

NCT Number: NCT06091800

Interleukin 20 and Periodontal Tisuue Destruction

Periodontitis is an inflammatory disease that causes destruction of periodontal tissues. IL-20, on the other hand, is known as a potent angiogenic, chemotactic, and pro-inflammatory cytokine associated with various chronic inflammatory disorders. IL-20 has a significant role in the regulation of osteoclastogenesis and osteoblastogenesis. The aim of this study was to evaluate the effect of IL-20 on periodontal destruction.

In the study, a total of 60 participants were included, 30 of whom were systemically and periodontally healthy (control group) and 30 of whom were systemically healthy and had periodontitis (periodontitis group). GCF and serum samples were collected from the participants for biochemical analysis. ELISA method was used to determine IL-20, TNF-α, IL1β/IL-10, RANKL/OPG and MMP8 levels

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Recep Tayyip Erdogan University

Rize, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The following criteria were required for inclusion: being systemically healthy, not smoking, not using antibiotics or systemic corticosteroids within the previous three months, not being pregnant or nursing, not having a chronic inflammatory disease, not receiving periodontal therapy within the previous six months, and possessing at least 20 teeth

Exclusion criteria

  • smoking, using antibiotics or systemic corticosteroids within the previous three months, pregnant, receiving periodontal therapy within the previous six months

Treatment and study plan

biochemical analysis

Other

GCF and serum samples were collected from the participants for biochemical analysis.

Primary outcomes

  1. concentration of biochemical findings in gingival crevicular fluid (GCF)

    Time frame: june 2022-june 2023

    IL-20, RANKL, OPG and RANKL/OPG values eveluated in GCF

  2. concentration of biochemical findings in serum

    Time frame: 1 year

    IL-20, RANKL, OPG, RANKL/OPG, MMP-8, TNF-α, IL-1β, IL-10 and IL-1β/IL-10

Secondary outcomes

  1. value of periodontal clinical parameters

    Time frame: 1 year

    plaque index (PI) (Silness & Löe), gingival index (GI) (Silness & Löe) and bleeding on probing index (BOP) of all natural teeth of the patients

  2. value of periodontal clinical parameters were measured in mm

    Time frame: 1 year

    probing pocket depth (PPD), clinical attachment loss (CAL) of all natural teeth of the patients

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University

Other

Registry information

Official study title

Determination of Levels of IL-20, TNF-α, IL1β/IL-10, RANKL/OPG and MMP8 in Serum and Gingival Crevicular Fluid (GCF) in Peridontally Healthy and Periodontitis Individuals

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 19, 2023
Registry last updated
Oct 19, 2023

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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