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

NCT07466095 | Not Yet Recruiting

• 1 other identifier: Biomarkers in pulpitis
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pulpitis - Irreversible; Pulpitis - Reversible

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  Single assessment at study visit

Interventions

IL-8 and Presepsin levels in the pulpal blood. DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adult Egyptian dental outpatients attending the diagnostic center at the Faculty of Dentistry, Cairo University.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

pulpal blood

Central Study Contacts

Sarah Shokry Ibrahim

CONTACT

00201091227355; sara.shokry@dentistry.cu.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Study Record Dates

• First Submitted: March 8, 2026
• First Posted: March 12, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03