NCT07073573

Evaluation of Pulpal Biomarkers in Vital Pulp Therapy

The Relationship Between Pulpal Biomarker Levels and the Success of Vital Pulp Therapy: A Prospective Clinical Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: ertuğrul karataş · Academic / Other
• Sex: All
• Age: 16 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The aim of this study is to identify the biomarkers that influence the success of vital pulp therapy (VPT), a treatment that offers several advantages over conventional root canal therapy. The study also aims to evaluate the success of VPT in teeth diagnosed with irreversible pulpitis. The success of VPT largely depends on the accurate assessment of pulpal status. This prospective clinical study will be conducted on 50 patients who apply to the Department of Endodontics, Faculty of Dentistry, Atatürk University, and meet the inclusion criteria. Informed consent will be obtained from all participants. A specially designed clinical assessment form will be completed for each patient to record clinical findings prior to the procedure. Local anesthesia will be administered using 1.8 mL of 4% articaine with 1:100,000 epinephrine. Following anesthesia, the teeth will be isolated using a rubber dam. Caries removal will be performed under an operating microscope (OPMI) using a diamond bur and aerator. All infected dentin will be removed selectively until hard dentin is reached. Pulpal bleeding will be controlled by applying a cotton pellet moistened with sterile saline into the cavity for one minute. Subsequently, pulpal fluid and blood samples will be collected using 5 mm-long sterile paper points to ensure equal sample volume per case. Each sample (one per patient) will be transferred into separate sterile Eppendorf tubes containing 500 µL of phosphate-buffered saline (PBS) and stored at -80°C until biochemical analysis. Total bleeding time will be recorded using a chronometer. The first tube will be used for the analysis of mediators including RANTES (CCL5), MCP-1, TNF-α, TGF-β, IL-1β, TIMP-1, MMP-12, and MMP-1. The second tube will be used to measure MDA, SDA, TAS, and TOS levels. After sample collection, the exposed pulp will be disinfected with a cotton pellet soaked in 2.5% sodium hypochlorite for 30 seconds. The cavity will then be rinsed with sterile saline and dried. The exposed pulp will be capped with Mineral Trioxide Aggregate (MTA) according to the manufacturer's instructions, and permanent restoration of the tooth will be completed. Patients will be recalled for follow-up evaluations at 3, 6, and 12 months, during which pulpal vitality will be assessed. A correlation will be established between biomarker levels and clinical success of the vital pulp therapy.

Conditions

• Reversible Pulpitis
• Irreversible Pulpitis
• Vital Pulp Therapy
• Dental Pulp Diseases

Interventions

Type	Name	Description
PROCEDURE	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

Timeline

• Start date: 2025-03-03
• Primary completion: 2025-07-25
• Completion: 2026-08-03
• First posted: 2025-07-18
• Last updated: 2025-07-20

Locations

1 site across 1 country: Turkey (Türkiye)