Biomarkers for Differentiating Reversible and Irreversible Pulpitis

NCT07658742 | Completed

• 1 other identifier: KURNAZ-PULPBIOMARKERS
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Reversible Pulpitis; Irreversible Pulpitis; Healthy Pulp

Keywords

Pulpitis; Irreversible Pulpitis; Pulp Blood; Biomarkers; Dental Pulp; ELISA

Outcome Measures

Primary Outcomes (1)

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

  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.

  At the time of treatment (baseline)

Secondary Outcomes (1)

• Diagnostic performance of pulpal blood biomarkers

  At the time of treatment (baseline)

Study Arms (3)

Normal Pulp

Teeth diagnosed with healthy pulp and scheduled for elective root canal treatment due to prosthetic indications.

Diagnostic Test: Pulpal Blood Biomarker Analysis

Reversible Pulpitis

Teeth diagnosed with reversible pulpitis based on clinical examination, radiographic findings, and pulp sensibility tests.

Diagnostic Test: Pulpal Blood Biomarker Analysis

Irreversible Pulpitis

Teeth diagnosed with irreversible pulpitis based on clinical examination, radiographic findings, and pulp sensibility tests.

Diagnostic Test: Pulpal Blood Biomarker Analysis

Interventions

Pulpal Blood Biomarker Analysis DIAGNOSTIC_TEST

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

Irreversible Pulpitis; Normal Pulp; Reversible Pulpitis

Eligibility Criteria

• Age: 12 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 12-35 years who presented to the Department of Endodontics or Pediatric Dentistry for routine restorative or root canal treatment and met the study eligibility criteria. Participants were classified into three groups according to pulpal diagnosis: normal pulp, reversible pulpitis, and irreversible pulpitis. Only systemically healthy individuals with vital teeth and sufficient pulpal blood sample collection during routine treatment procedures were included.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Safa: lead

Study Sites (1)

Kütahya Health Sciences University Faculty of Dentistry

Kütahya, Kütahya, 43100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulpitis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: June 14, 2026
• First Posted: June 22, 2026
• Study Start: November 1, 2025
• Primary Completion: June 1, 2026
• Study Completion: June 10, 2026
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)