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Bioactive Materials in Vital Pulp Therapy of Permanent Teeth

NCT07562555 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-05-01

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Ege University

    lead OTHER

Principal Investigators

  • Gözde Kandemir Demirci, Associate Professor · Ege University Faculty of Dentistry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-10
Primary Completion
2026-04-10
Completion
2026-04-10

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07562555 on ClinicalTrials.gov