Evaluation of Pulpal Biomarkers in Vital Pulp Therapy

ertuğrul karataş

Status

Active, not recruiting

Conditions

Dental Pulp Diseases

Irreversible Pulpitis

Reversible Pulpitis

Vital Pulp Therapy

Treatments

Procedure: Vital pulp therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT07073573

B.30.2.ATA.0.01.00/535

NO-FUNDING-TRIAL-2025 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

16 to 40 years old

Volunteers

No Healthy Volunteers

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