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

Official title

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

Overview

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.

Interventions

• Diagnostic test IL-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.

Primary outcome measures

• The primary outcome of this study is the correlation of two specific biomarkers IL-8 and Presepsin in the dental pulp tissue with different pulpal status [Time frame: Single assessment at study visit]

Eligibility criteria

Inclusion criteria

• Male and female patients. Age between 14 years and 50 years . Diagnosis established in accordance with the American Association of Endodontists (AAE) (2013) for normal pulp, reversible pulpitis, or symptomatic irreversible pulpitis. Participants will be asked if they wish to be included in the study (implying informed consent).

Normal pulp Sound, unrestored non-carious vital teeth will be included. The teeth with healthy pulp. The teeth indicated for orthodontic extraction or elective root canal treatment before prosthodontic intervention.

There with no clinical signs or symptoms of pulpitis. There with no history of pain. The response to the cold test within normal limits. No sensitivity to percussion. No periodontal ligament space widening (Periapical Index (PAI) = 1). Teeth with Reversible Pulpitis \[RP\] Medically healthy patients will be included.

Patients with extremely deep carious lesion (according to Bjørndal, 2017) One or more of the following signs and symptoms present:

Clinical symptoms of minor intensity. Slightly exaggerated reaction to cold or sweet stimuli. No history of spontaneous pain. Response to the cold test within normal limits. No sensitivity to chewing. No sensitivity to percussion. No widening of the periodontal ligament space (Periapical Index (PAI) = 1). Teeth with Irreversible Pulpitis \[IRP\] Medically healthy patients will be included. Patients with extremely deep carious lesion

One or more of the following signs and symptoms were present:

History of continuous moderate or severe pain. Either provoked or spontaneous lingering pain initiated by provocation (cold test).

Tenderness to chewing or percussion. No widening of the periodontal ligament space (Periapical Index (PAI) = 1) (Orstavik,1988)

Exclusion criteria

• Absence of a response to pulp sensibility tests. Non-restorable teeth. Periodontal involvement. Presence of a sinus tract. Presence of periapical pathology on radiograph. Presence of resorption (external or internal). Cracked teeth. Immature teeth with an open apex. Presence of any systemic disease. Pregnant females. History of intake of Non-Steroidal Anti-inflammatory Drugs (NSAIDs) or antibiotics within the last 1 week.

Patients who needed prophylactic antibiotics. No pulp exposure after complete caries removal. Inadequate blood volume collection after pulpal exposure.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07466095 · Biomarkers in pulpitis

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗