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Biomarkers for Differentiating Reversible and Irreversible Pulpitis

Role of Inflammatory, Oxidative Stress, Neurogenic, and Immunological Biomarkers in Pulp Blood for the Differential Diagnosis of Reversible and Irreversible Pulpitis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07658742
Acronym
PULPBIOM
Enrollment
90
Registered
2026-06-22
Start date
2025-11-01
Completion date
2026-06-10
Last updated
2026-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Pulp, Irreversible Pulpitis, Reversible Pulpitis

Keywords

Pulpitis, Irreversible Pulpitis, Pulp Blood, Biomarkers, Dental Pulp, ELISA

Brief 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.

Detailed description

Current diagnosis of pulpal status relies primarily on clinical symptoms, sensibility tests, and radiographic findings, which may not always accurately reflect the underlying histopathological condition of the pulp. This study aims to investigate inflammatory, neurogenic, immunological, and oxidative stress biomarkers obtained from pulpal blood samples collected during routine dental treatment. Biomarker levels will be compared among teeth with normal pulp, reversible pulpitis, and irreversible pulpitis. The findings may contribute to the development of objective diagnostic tools for more accurate differentiation of pulpal conditions and improved treatment decision-making.

Interventions

DIAGNOSTIC_TESTPulpal Blood Biomarker Analysis

Collection of pulpal blood samples during routine dental treatment followed by biomarker analysis using ELISA.

Sponsors

Safa
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
12 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* Individuals aged 12 to 35 years * Systemically healthy individuals * Patients presenting for routine restorative treatment or root canal treatment * Teeth classified into one of the following pulpal status groups: healthy pulp, reversible pulpitis, or irreversible pulpitis * Confirmation of pulp vitality by pulp sensibility tests * Ability to obtain pulp exposure and collect an adequate pulpal blood sample during treatment

Exclusion criteria

* No response to pulp sensibility tests * Teeth that are not restorable * Presence of a sinus tract * Radiographic evidence of periapical pathology * Presence of internal or external root resorption * Teeth with open apices * Presence of systemic disease * Pregnancy * History of non-steroidal anti-inflammatory drug (NSAID) or antibiotic use within the last week * Requirement for prophylactic antibiotic use * Teeth in which pulp exposure cannot be achieved after complete caries removal

Design outcomes

Primary

MeasureTime frameDescription
Levels of inflammatory, neurogenic, immunological, and oxidative stress biomarkers in pulpal blood samplesAt the time of treatment (baseline)Comparison of tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), interleukin-10 (IL-10), matrix metalloproteinase-9 (MMP-9), transforming growth factor-beta 1 (TGF-β1), presepsin, substance p, semaphoric 3A (SEMA3A), semaphoric 4D (SEMA4D), semaphoric 7A (SEMA7A), total antioxidant status (TAS), total oxidant status (TOS), malondialdehyde (MDA), glutathione (GSH), and superoxide dismutase (SOD) levels among healthy pulp, reversible pulpitis, and irreversible pulpitis groups.

Secondary

MeasureTime frameDescription
Diagnostic performance of pulpal blood biomarkersAt the time of treatment (baseline)Evaluation of the ability of measured biomarkers to differentiate healthy pulp, reversible pulpitis, and irreversible pulpitis.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 1, 2026