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NCT07466095

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

Sponsor: Cairo University

View on ClinicalTrials.gov

Summary

Observational cross-sectional study aims 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

Key Details

Gender

All

Age Range

14 Years - 50 Years

Study Type

OBSERVATIONAL

Enrollment

Start Date

2026-11-01

Completion Date

2027-12-01

Last Updated

2026-03-12

Healthy Volunteers

Yes

Conditions

Pulpitis - Irreversible Pulpitis - Reversible

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.

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.