CompletedNot Applicable

Biomarkers for Differentiating Reversible and Irreversible Pulpitis

Turkey (Türkiye)90 participantsStarted 2025-11-01

Plain-language 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 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.

Who can participate

Age range

12 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: At the time of treatment (baseline)

Trial details

NCT IDNCT07658742

SponsorSafa

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-06-01

View on ClinicalTrials.gov More Reversible Pulpitis trials