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Pulpitis - IrreversibleCross-sectionNCT07466095

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

An observational study of Pulpitis - Irreversible and Pulpitis - Reversible, run by Cairo University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 14 to 50 yearsHealthy volunteers can take part
What is being tested?
IL-8 and Presepsin levels in the pulpal blood.
How many people
50 participants
Where
No sites listed yet
Study dates
1 Nov 2026to 1 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

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

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

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

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

Read the 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.

Being tested
IL-8 and Presepsin levels in the pulpal blood.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Single assessment at study visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion1 Nov 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07466095
Sponsor's protocol ID
Biomarkers in pulpitis
Acronym
Cross-section
Status last verified
Mar 2026
First submitted
8 Mar 2026
Last updated
12 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Pulpitis - Irreversible and Pulpitis - Reversible, run by Cairo University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sarah Shokry Ibrahim (00201091227355, sara.shokry@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.

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