Bioactive Materials in Vital Pulp Therapy of Permanent Teeth

NCT07562555 | Completed DMC

• 2 other identifiers: 24-3.1/532695
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical study aimed to evaluate and compare the clinical, radiographic, and postoperative pain outcomes of direct pulp capping performed using two calcium silicate-based materials: ProRoot MTA and Biofactor MTA in permanent teeth with vital pulp exposure. A total of 80 teeth were randomly allocated into two groups according to the capping material used. Following standardized caries removal and achievement of hemostasis, direct pulp capping was performed using either ProRoot MTA or Biofactor MTA under similar clinical conditions. Definitive coronal restorations were completed 24 hours after the procedure. Postoperative pain was assessed using a numerical rating scale (NRS) at 0, 6, 12, 24, and 48 hours after treatment. Patients were instructed to record their pain levels and analgesic intake during this period. Patients were recalled for clinical and radiographic evaluations at 6 and 12 months. Clinical success was defined as the absence of spontaneous pain, sensitivity, swelling, sinus tract formation, and tenderness to percussion or palpation. Radiographic success was determined by the absence of periapical pathology. Additionally, the influence of demographic and clinical variables, including age, gender, characteristics of pulp exposure, and intraoperative factors, on treatment outcomes and pulpal healing was evaluated.

Conditions

Vital Pulp Therapy

Keywords

dental pulp; bioactive material; direct pulp capping; endodontics

Outcome Measures

Primary Outcomes (1)

• Clinical and radiographic success of direct pulp capping

  Treatment success defined as the absence of clinical symptoms, including spontaneous pain, sensitivity, swelling, sinus tract formation, and tenderness to percussion or palpation, together with the absence of radiographic signs of pathology such as periapical radiolucency.

  1 year follow-up

Secondary Outcomes (1)

• Postoperative pain intensity following direct pulp capping

  up to 2-day

Study Arms (2)

ProRoot MTA

ACTIVE COMPARATOR

In this group, direct pulp capping procedures were performed using ProRoot MTA. Following caries removal under water cooling with a sterile round diamond bur and spoon excavator, teeth with pulp exposure were included in the study. Hemostasis was achieved. ProRoot MTA was then placed directly over the exposed pulp tissue according to the manufacturer's instructions. A protective base was applied over the material, and the cavity was temporarily restored. Definitive coronal restoration was completed 24 hours after the procedure.

Procedure: Direct pulp capping with ProRoot MTA

BIOfactor MTA

EXPERIMENTAL

In this group, direct pulp capping procedures were performed using BIOfactor MTA. Following caries removal under water cooling with a sterile round diamond bur and spoon excavator, teeth with pulp exposure were included in the study. Hemostasis was achieved. BIOfactor MTA was placed over the exposure site in accordance with the manufacturer's recommendations. A protective base material was applied, and temporary restoration was performed. Permanent coronal restoration was completed 24 hours later.

Procedure: Direct pulp capping with BIOfactor MTA

Interventions

Direct pulp capping with ProRoot MTA PROCEDURE

Direct pulp capping was performed using ProRoot MTA after caries removal and hemostasis. The material was placed over the pulp exposure, and definitive restoration was completed after 24 hours.

ProRoot MTA

Direct pulp capping with BIOfactor MTA PROCEDURE

Direct pulp capping was performed using Biofactor MTA following caries removal and hemostasis. The material was applied directly over the exposed pulp, and definitive restoration was completed after 24 hours.

BIOfactor MTA

Eligibility Criteria

• Age: 13 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged between 13 and 65 years
• Patients with adequate patient-clinician communication
• Patients who agree to attend periodic follow-up visits throughout the study
• Patients who provide written informed consent to participate in the study
• Systemically healthy patients
• Teeth with no previous endodontic treatment
• Teeth showing a positive response to cold and electric pulp test
• Permanent teeth
• Posterior teeth
• Teeth that can be restored with direct composite restoration
• Teeth with pulp exposure (pulpal perforation)
• Presence of bleeding from the exposed pulp that can be controlled within 5-10 minutes

You may not qualify if:

• Patients who refuse to participate in the study
• Medically compromised patients (e.g., patients with systemic diseases, immunological disorders, or those using medications)
• Patients with known allergies to materials used during vital pulp therapy
• Pregnant patients
• Non-vital teeth
• Presence of advanced periodontal disease (probing depth \> 3 mm)
• Teeth with previous endodontic treatment
• Teeth with insufficient remaining tooth structure that cannot be restored with restorative materials
• Teeth where adequate isolation cannot be achieved
• Teeth requiring post core restoration
• Patients in whom periapical radiographs cannot be obtained
• Patients unable to attend follow-up visits
• Cases in which bleeding from the exposed pulp cannot be controlled within 5-10 minutes

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University Faculty of Dentistry

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

ProRoot MTA

Study Officials

• Gözde Kandemir Demirci, Associate Professor

  Ege University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2026
• First Posted: May 1, 2026
• Study Start: January 10, 2025
• Primary Completion: April 10, 2026
• Study Completion: April 10, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)