Ireland
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Evaluation of Pulpal Biomarkers in Vital Pulp Therapy

NCT07073573 · tracked via the Priya Life Science Turkey tracker
Sponsor
ertuğrul karataş
Phase
Not applicable
Started
2025-03-03
Last updated
2025-07-20

Condition(s) studied

Reversible PulpitisIrreversible PulpitisVital Pulp TherapyDental Pulp Diseases

Investigational drug(s) / intervention(s)

Vital pulp therapy

Vital pulp therapy: Vital pulp therapy was performed using a calcium silicate-based material after caries removal and coronal pulp exposure. Hemostasis was achieved using sodium hypochlorite before placing the material. Permanent restoration was completed in the same session. Pulpal fluid samples were collected before the intervention to assess biomarker levels. The relationship between biomarker expression and the clinical success or longevity of the treated teeth was evaluated over time

Study summary

This prospective clinical study aims to evaluate the association between the levels of selected pulpal biomarkers and the clinical success of vital pulp therapy in permanent teeth. Patients undergoing vital pulp therapy will be monitored over time, and biomarker expression levels will be analyzed in relation to treatment outcomes. The study intends to provide insight into the predictive value of pulp tissue biomarkers for long-term success in vital pulp procedures.

Eligibility

Sex
ALL
Min age
16 Years
Max age
40 Years
Healthy volunteers
No
Inclusion Criteria: * Permanent teeth diagnosed with reversible pulpitis * Patients diagnosed with irreversible pulpitis but without apical radiolucency * Teeth showing a normal response to cold testing (carbon dioxide snow) * Teeth with irreversible pulpitis demonstrating prolonged response to cold testing * Teeth with no sensitivity to percussion or chewing * In teeth with exposed pulp tissue, bleeding time less than 5 minutes * In irreversible pulpitis cases, bleeding time less than 10 minutes * No widening of the periodontal ligament space (periapical index \[PAI\] ≤ 2) * Radiographic evidence of deep dentinal caries Exclusion Criteria: * Teeth with a negative response to cold testing (carbon dioxide snow) * Presence of apical radiolucency (PAI \> 2) * Condensed apical periodontitis * Internal or external root resorption * History of dental trauma * Longitudinal root fracture * Presence of periodontal-endodontic lesions on the day of treatment * Functional loss (e.g., Grade 3 tooth mobility) * Swelling associated with the treated tooth * Teeth that cannot be treated under rubber dam isolation * Teeth from which less than 2.5 mL of pulpal blood can be collected * Immunocompromised individuals * Pregnant women at the time of treatment * Use of antibiotics, bisphosphonates, or statins within 4 weeks prior to treatment

Primary outcome measure(s)

  • Clinical success of treated teeth with Vital Pulp Therapy — 6-12 months after treatment
    Clinical and radiographic success will be defined as the absence of symptoms (e.g., spontaneous pain, swelling), no sinus tract, no pathological mobility, and no periapical radiolucency. In addition, a positive response to pulp vitality tests (e.g., cold test or EPT) will be considered as an indicator of maintained pulpal vitality.

Trial sites (1)

FacilityCityRegionStatus
Ataturk University, Faculty of Dentistry, Department of Endodontics Erzurum Erzurum
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07073573 on ClinicalTrials.gov ↗ ← All trials in Turkey