Bioactive Materials in Vital Pulp Therapy of Permanent Teeth

Evaluation of the Effect of Two Different Bioactive Materials on the Success of Vital Pulp Therapy in Permanent Teeth: A Prospective Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: Vital Pulp Therapy
• Intervention / Treatment: Procedure: Direct pulp capping with ProRoot MTA; Procedure: Direct pulp capping with BIOfactor MTA

Detailed Description

This randomized controlled clinical study was designed to evaluate and compare the clinical performance, radiographic outcomes, postoperative pain, and pulpal healing following direct pulp capping using two calcium silicate-based materials: ProRoot MTA and Biofactor MTA in permanent teeth with vital pulp exposure.

A total of 80 teeth diagnosed with vital pulp requiring direct pulp capping were included in the study. Participants were randomly allocated into two equal groups (n=40) according to the pulp capping material used. All procedures were carried out under standardized clinical conditions.

Caries removal was performed using a sterile round diamond bur under water cooling, followed by excavation with a spoon excavator. Teeth with pulp exposure were included in the study. Hemostasis was achieved. In cases where bleeding could not be controlled within a clinically acceptable time, the tooth was excluded from the study.

In the experimental group, Biofactor MTA was applied directly over the exposed pulp tissue according to the manufacturer's instructions. In the control group, ProRoot MTA was used following the same protocol. After placement of the capping material, a protective base was applied, and the cavity was temporarily restored. Definitive coronal restorations were completed 24 hours after the initial procedure.

Postoperative pain was evaluated using a Numerical Rating Scale (NRS) at 0, 6, 12, 24, and 48 hours following treatment. Patients were instructed to record their pain intensity and the number of analgesic tablets taken during this period.

Patients were recalled for follow-up examinations at 6 and 12 months. Clinical evaluation included assessment of spontaneous pain, sensitivity, swelling, sinus tract formation, tenderness to percussion and palpation, and periodontal probing depths. Radiographic evaluation was performed to assess the presence of periapical pathology.

Treatment success was defined as the absence of clinical symptoms and the absence of radiographic signs of pathology.

Furthermore, the influence of demographic and clinical variables, including age, gender, number and location of pulp exposures, size of exposure, and bleeding control time, on treatment outcomes was analyzed.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Izmir, Turkey (Türkiye), 35100
    • Ege University Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ProRoot MTA; 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; 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.
Experimental: BIOfactor MTA; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain intensity following direct pulp capping	Postoperative pain will be evaluated using a Numerical Rating Scale (NRS), where patients rate their pain intensity at predefined time intervals after treatment. The Numerical Rating Scale is a pain measurement scale that encompasses the following grades: 0 no pain, 1-3 mild pain, 4-6 moderate pain, 7-10 severe pain. Patients will be instructed to record their pain levels and analgesic intake.	up to 2-day

Collaborators and Investigators

• Sponsor: Ege University
• Investigators: Principal Investigator: Gözde Kandemir Demirci, Associate Professor, Ege University Faculty of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2025
• Primary Completion (Actual): April 10, 2026
• Study Completion (Actual): April 10, 2026

Study Registration Dates

• First Submitted: April 25, 2026
• First Submitted That Met QC Criteria: April 25, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 25, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: endodontics; dental pulp; bioactive material; direct pulp capping
• Additional Relevant MeSH Terms: ProRoot MTA
• Other Study ID Numbers: 24-3.1/5; 32695 (Other Grant/Funding Number: Ege University Scientific Research Projects Coordination Unit (BAP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No