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Bioactive Materials in Vital Pulp Therapy of Permanent Teeth

2026年4月25日 更新者：Gözde Kandemir Demirci、Ege University

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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

80

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

是的

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：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.
程序：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.
实验性的：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.
程序：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Clinical and radiographic success of direct pulp capping
大体时间：1 year follow-up
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

次要结果测量

结果测量
措施说明
大体时间
Postoperative pain intensity following direct pulp capping
大体时间：up to 2-day
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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Ege University

调查人员

  • 首席研究员：Gözde Kandemir Demirci, Associate Professor、Ege University Faculty of Dentistry

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年1月10日

初级完成 (实际的)

2026年4月10日

研究完成 (实际的)

2026年4月10日

研究注册日期

首次提交

2026年4月25日

首先提交符合 QC 标准的

2026年4月25日

首次发布 (实际的)

2026年5月1日

研究记录更新

最后更新发布 (实际的)

2026年5月1日

上次提交的符合 QC 标准的更新

2026年4月25日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 24-3.1/5
  • 32695 (其他赠款/资助编号：Ege University Scientific Research Projects Coordination Unit (BAP))

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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