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Completed
NCT07658742
Biomarkers for Differentiating Reversible and Irreversible Pulpitis
Conditions: Reversible Pulpitis, Irreversible Pulpitis, Healthy Pulp
Sex: All
Ages: 12 Years – 35 Years
Healthy volunteers: Yes
Enrollment: 90
Sponsor: Safa
Location: Kütahya Health Sciences University Faculty of Dentistry Kütahya Kütahya
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07658742). StuddyBuddy aggregates publicly available trial information.