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Biomarkers for Differentiating Reversible and Irreversible Pulpitis (PULPBIOM)

14. juni 2026 opdateret af: Safa

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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

90

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyrkiet (Türkiye)
    • Kütahya
      • Kütahya, Kütahya, Tyrkiet (Türkiye), 43100
        • Kütahya Health Sciences University Faculty of Dentistry

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Normal Pulp
Teeth diagnosed with healthy pulp and scheduled for elective root canal treatment due to prosthetic indications.
Diagnostisk test: Pulpal Blood Biomarker Analysis
Collection of pulpal blood samples during routine dental treatment followed by biomarker analysis using ELISA.
Reversible Pulpitis
Teeth diagnosed with reversible pulpitis based on clinical examination, radiographic findings, and pulp sensibility tests.
Diagnostisk test: Pulpal Blood Biomarker Analysis
Collection of pulpal blood samples during routine dental treatment followed by biomarker analysis using ELISA.
Irreversible Pulpitis
Teeth diagnosed with irreversible pulpitis based on clinical examination, radiographic findings, and pulp sensibility tests.
Diagnostisk test: Pulpal Blood Biomarker Analysis
Collection of pulpal blood samples during routine dental treatment followed by biomarker analysis using ELISA.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Levels of inflammatory, neurogenic, immunological, and oxidative stress biomarkers in pulpal blood samples
Tidsramme: 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.
At the time of treatment (baseline)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Diagnostic performance of pulpal blood biomarkers
Tidsramme: At the time of treatment (baseline)
Evaluation of the ability of measured biomarkers to differentiate healthy pulp, reversible pulpitis, and irreversible pulpitis.
At the time of treatment (baseline)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Safa

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. november 2025

Primær færdiggørelse (Faktiske)

1. juni 2026

Studieafslutning (Faktiske)

10. juni 2026

Datoer for studieregistrering

Først indsendt

14. juni 2026

Først indsendt, der opfyldte QC-kriterier

14. juni 2026

Først opslået (Faktiske)

22. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KURNAZ-PULPBIOMARKERS

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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