Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:51 AM
Study NCT ID:
NCT07466095
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-12
First Post:
2026-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Cross-sectional Study Aiming to Determine the Correlation Between Pulpal Status and IL-8 and Presepsin Levels in the Pulpal Blood.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'pulpal blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-08', 'studyFirstSubmitDate': '2026-03-08', 'studyFirstSubmitQcDate': '2026-03-08', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': 'Single assessment at study visit', 'description': '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.\n\nPresepsin: 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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulpitis - Irreversible', 'Pulpitis - Reversible']}, 'descriptionModule': {'briefSummary': 'Observational cross-sectional study aims to determine the correlation between pulpal status and IL-8 and Presepsin levels in the pulpal blood.', 'detailedDescription': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult Egyptian dental outpatients attending the diagnostic center at the Faculty of Dentistry, Cairo University.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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).\n\nNormal 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.\n\nThere 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.\n\nPatients with extremely deep carious lesion (according to Bjørndal, 2017) One or more of the following signs and symptoms present:\n\nClinical 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\n\nOne or more of the following signs and symptoms were present:\n\nHistory of continuous moderate or severe pain. Either provoked or spontaneous lingering pain initiated by provocation (cold test).\n\nTenderness to chewing or percussion. No widening of the periodontal ligament space (Periapical Index (PAI) = 1) (Orstavik,1988)\n\nExclusion Criteria:\n\n* 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.\n\nPatients who needed prophylactic antibiotics. No pulp exposure after complete caries removal. Inadequate blood volume collection after pulpal exposure.'}, 'identificationModule': {'nctId': 'NCT07466095', 'acronym': 'Cross-section', 'briefTitle': 'Observational Cross-sectional Study Aiming to Determine the Correlation Between Pulpal Status and IL-8 and Presepsin Levels in the Pulpal Blood.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'Biomarkers in pulpitis'}}, 'armsInterventionsModule': {'interventions': [{'name': 'IL-8 and Presepsin levels in the pulpal blood.', 'type': 'DIAGNOSTIC_TEST', 'description': '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.\n\nPresepsin: 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.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sarah Shokry Ibrahim', 'role': 'CONTACT', 'email': 'sara.shokry@dentistry.cu.edu.eg', 'phone': '00201091227355'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD candidate', 'investigatorFullName': 'Sarah Shokry Ibrahim Mohammed', 'investigatorAffiliation': 'Cairo University'}}}}