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Not Yet RecruitingNCT07466095

Observational Cross-sectional Study Aiming to Determine the Correlation Between Pulpal Status and IL-8 and Presepsin Levels in the Pulpal Blood.

Assessing the Differential Performance of the Inflammatory Biomarkers Interleukin-8 and Presepsin in Patients Exhibiting Clinical Symptoms Suggestive of Reversible and Irreversible Pulpitis: A Preliminary Cross -Sectional Study

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
50 (estimated)
Sponsor
Cairo University · Academic / Other
Sex
All
Age
14 Years – 50 Years
Healthy volunteers
Accepted

Summary

Observational cross-sectional study aims to determine the correlation between pulpal status and IL-8 and Presepsin levels in the pulpal blood.

Detailed description

Pulpitis is a complex biological defence mechanism that aims to protect the dental pulp from damage while also encouraging healing and repair. This response occurs when the body interacts with pathogens, leading to local immune and pulp cells organizing an inflammatory reaction. This reaction involves the widening of blood vessels, the release of substances that cause inflammation, and the movement of immune cells to the site of the injury. Establishing an accurate diagnosis of the pulpal state represents the fundamental prerequisite for the initiation of appropriate treatment. Unfortunately, this stage can be significantly complicated by the inherent limitations of existing diagnostic procedures. In such circumstances, biomarkers assume considerable importance. Concerning the diagnosis of endodontic conditions, clinical symptomatology is typically prioritized over histologic findings, given that the examination of pulp tissue via histology is not feasible in the majority of these scenarios. Consequently, the identification of specific biomarkers holds the potential to facilitate more precise diagnostic assessments. The recent advancement of pulpal diagnostic tools that utilize inflammatory biomarkers has become a key focus for researchers in endodontics. This approach to molecular pulpal diagnosis involves evaluating the concentrations of inflammatory biomarkers, including cytokines, chemokines, prostaglandins, and growth factors found in pulp tissue, pulpal blood, dentinal fluid, and gingival crevicular fluid. Interleukin-8 (IL-8), a pro-inflammatory cytokine produced by dental pulp cells, plays a significant role in the inflammatory response. It boosts the presence of polymorphonuclear neutrophils (PMNs) in the pulp tissue by attracting them and causing them to release their content. IL-8 is frequently regarded as the main controlling molecule during the initial, acute phase of inflammation. Presepsin, also known as soluble CD14 subtype (sCD14-ST), is a crucial inflammatory biomarker derived from the breakdown of pro-kallikrein 1. Its levels significantly increase in response to systemic inflammatory conditions as septic shock and various infections, making it a promising indicator for early diagnosis and prognosis in critical illnesses. Clinically, measuring presepsin can facilitate prompt diagnosis of septic shock and aid in monitoring treatment efficacy. Beyond systemic applications, presepsin is also being evaluated for its role in localized inflammatory conditions such as dental pulp and periodontal inflammation. It serves a vital biological role in the immune response by helping to recognize pathogens and initiate inflammation. Clinically, presepsin levels can be quantitatively assessed in blood or pulp tissue samples, providing objective data that complements traditional clinical signs (like pain and swelling) and radiographic findings, thereby enhancing diagnostic precision.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTIL-8 and Presepsin levels in the pulpal blood.Interleukin-8 (IL-8): This is a pro-inflammatory chemokine. The outcome will be the quantified level of IL-8, likely measured in picograms per milliliter (pg/mL) , obtained from pulp tissue samples. Presepsin: This is likely a precursor to pepsinogen, which can be involved in inflammatory processes. The outcome will be the quantified level of Presepsin, likely measured in similar units as IL-8, obtained from pulp tissue samples.

Timeline

Start date
2026-11-01
Primary completion
2027-11-01
Completion
2027-12-01
First posted
2026-03-12
Last updated
2026-03-12

Source: ClinicalTrials.gov record NCT07466095. Inclusion in this directory is not an endorsement.