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NCT Number: NCT07658742

Biomarkers for Differentiating Reversible and Irreversible Pulpitis

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 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.

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Key information

Conditions

Reversible Pulpitis Dental Pulp Diseases Healthy Pulp Irreversible Pulpitis Pulpitis Stomatognathic Diseases Tooth Diseases

Age range

12 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kütahya Health Sciences University Faculty of Dentistry

Kütahya, 43100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

Pulpal Blood Biomarker Analysis

Diagnostic Test

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

Primary outcomes

  1. Levels of inflammatory, neurogenic, immunological, and oxidative stress biomarkers in pulpal blood samples

    Time frame: At the time of treatment (baseline)

    Comparison of TNF-α, IL-6, IL-10, MMP-9, TGF-β1, Presepsin, Substance P, SEMA3A, SEMA4D, SEMA7A, TAS, TOS, MDA, GSH, and SOD levels among healthy pulp, reversible pulpitis, and irreversible pulpitis groups.

Secondary outcomes

  1. Diagnostic performance of pulpal blood biomarkers

    Time frame: At the time of treatment (baseline)

    Evaluation of the ability of measured biomarkers to differentiate healthy pulp, reversible pulpitis, and irreversible pulpitis.

Sponsors and collaborators

Lead sponsor

Safa

Other

Registry information

Official study title

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

Acronym: PULPBIOM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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