NCT06091800

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 19, 2023

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

9 months

First QC Date

October 11, 2023

Last Update Submit

October 18, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • concentration of biochemical findings in gingival crevicular fluid (GCF)

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

    june 2022-june 2023

  • concentration of biochemical findings in serum

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

    1 year

Secondary Outcomes (2)

  • value of periodontal clinical parameters

    1 year

  • value of periodontal clinical parameters were measured in mm

    1 year

Study Arms (2)

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

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

Interventions

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

control group (periodontally healthy)periodontitis group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study included individuals who applied to Recep Tayyip Erdogan University, Faculty of Dentistry, Department of Periodontology for treatment

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recep Tayyip Erdogan University

Rize, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum and gingival crevicular fluid

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Yemenoglu

    Recep Tayyip Erdogan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

October 11, 2023

First Posted

October 19, 2023

Study Start

June 6, 2022

Primary Completion

March 6, 2023

Study Completion

June 6, 2023

Last Updated

October 19, 2023

Record last verified: 2023-10

Locations