Interleukin 20 and Periodontal Tisuue Destruction

Sponsor
Recep Tayyip Erdogan University (Other)
Overall Status
Completed
CT.gov ID
NCT06091800
Collaborator
(none)
60
1
12
5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: biochemical analysis

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
60 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official 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
Actual Study Start Date :
Jun 6, 2022
Actual Primary Completion Date :
Mar 6, 2023
Actual Study Completion Date :
Jun 6, 2023

Arms and Interventions

Arm Intervention/Treatment
control group (periodontally healthy)

no attachment loss, probing pocket depth ≤ 3 mm, minimal bleeding on probing ≤ 10%, and no radiographic bone loss

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

periodontitis group

interdental clinical attachment level ≥ 5 mm, probing pocket depth ≥ 6 mm, radiographic bone loss extending to the middle or apical thirds of the root, mid-crest defect, and a history of ≤4 teeth loss of periodontal origin

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

Outcome Measures

Primary Outcome Measures

  1. concentration of biochemical findings in gingival crevicular fluid (GCF) [june 2022-june 2023]

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

  2. concentration of biochemical findings in serum [1 year]

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

Secondary Outcome Measures

  1. value of periodontal clinical parameters [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 [1 year]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Recep Tayyip Erdogan University Rize Turkey

Sponsors and Collaborators

  • Recep Tayyip Erdogan University

Investigators

  • Principal Investigator: Yemenoglu, Recep Tayyip Erdogan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hatice Yemenoglu, assistant professor, Recep Tayyip Erdogan University
ClinicalTrials.gov Identifier:
NCT06091800
Other Study ID Numbers:
  • RecepTayyip ErdoganUniversity
  • Recep Tayyip ErdoganUniversity
First Posted:
Oct 19, 2023
Last Update Posted:
Oct 19, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 19, 2023