Evaluation of Pulpal Biomarkers in Vital Pulp Therapy

NCT07073573 | Active Not Recruiting

• 2 other identifiers: B.30.2.ATA.0.01.00/535NO-FUNDING-TRIAL-2025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Pulpal Biomarkers; Vital Pulp Therapy; Inflammatory Cytokines; Dental Pulp Inflammation; Clinical Success; Biomarker Expression

Outcome Measures

Primary Outcomes (1)

• Clinical success of treated teeth with Vital Pulp Therapy

  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.

  6-12 months after treatment

Study Arms (2)

reversible pulpitis

ACTIVE COMPARATOR

Patients diagnosed with reversible pulpitis and treated accordingly

Procedure: Vital pulp therapy

Irreversible Pulpitis

ACTIVE COMPARATOR

Patients diagnosed with irreversible pulpitis and treated accordingly

Procedure: Vital pulp therapy

Interventions

Vital pulp therapy PROCEDURE

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

Also known as: Partial pulpotomy, Pulpotomy

Irreversible Pulpitis; reversible pulpitis

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ertuğrul karataş: lead

Study Sites (1)

Ataturk University, Faculty of Dentistry, Department of Endodontics

Erzurum, Erzurum, 25070, Turkey (Türkiye)

Location

Related Publications (2)

• Iaculli F, Rodriguez-Lozano FJ, Briseno-Marroquin B, Wolf TG, Spagnuolo G, Rengo S. Vital Pulp Therapy of Permanent Teeth with Reversible or Irreversible Pulpitis: An Overview of the Literature. J Clin Med. 2022 Jul 11;11(14):4016. doi: 10.3390/jcm11144016.

  PMID: 35887779 BACKGROUND

• Asgary S, Nosrat A. Vital Pulp Therapy: Evidence-Based Techniques and Outcomes. Iran Endod J. 2025;20(1):e2. doi: 10.22037/iej.v20i1.47141. Epub 2025 Jan 1.

  PMID: 39935864 BACKGROUND

MeSH Terms

Conditions

Dental Pulp Diseases

Interventions

Pulpotomy

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were blinded to their group assignment, but investigators were aware of the clinical group classification.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Endodontics

Model Details: Participants will be assigned to one of two parallel arms based on clinical diagnosis: reversible pulpitis or irreversible pulpitis

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 18, 2025
• Study Start: March 3, 2025
• Primary Completion: July 25, 2025
• Study Completion (Estimated): August 3, 2026
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)