Clinical Trial

Biomarkers for Differentiating Reversible and Irreversible Pulpitis

Study acronym: PULPBIOM
Completed
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Summary
This observational study aims to evaluate the role of inflammatory, oxidative stress, neurogenic, and immunological biomarkers obtained from pulpal blood in the differential diagnosis of normal pulp, reversible pulpitis, and irreversible pulpitis. A total of 75 teeth from systemically healthy individuals aged 12-35 years will be included and classified into three groups: normal pulp, reversible pulpitis, and irreversible pulpitis, based on clinical examination, radiographic findings, and pulp sensibility tests. No additional treatment procedures will be performed for research purposes. All dental procedures will be carried out according to routine clinical protocols. During routine treatment, after pulp exposure, approximately 50 μL of pulpal blood that would otherwise be discarded as medical waste will be collected using a micropipette. Samples will be stored and analyzed using Enzyme-Linked ImmunoSorbent Assay (ELISA) to determine the levels of inflammatory, neurogenic, immunological, and oxidative stress biomarkers. The results will be compared among the three groups to identify biomarkers that may improve the accuracy of pulpitis diagnosis and support clinical decision-making.
Trial Details
NCT Number NCT07658742
Lead Sponsor Safa
Conditions Reversible Pulpitis, Irreversible Pulpitis, Healthy Pulp
Enrollment 90 participants
Start Date 2025-11-01
Primary Completion 2026-06-01 (estimated)
Study Completion 2026-06-10 (estimated)
Updated on ClinicalTrials.gov 2026-07-31