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Laser Assisted Pulpotomy Versus MTA Pulpotomy in Permanent Teeth With Irreversible Pulpitis

2026年8月8日 更新者:Nessrin Taha、King Abdullah University Hospital

Comparative Evaluation of Diode Laser-Assisted Pulpotomy Versus MTA Pulpotomy in Permanent Teeth With Irreversible Pulpitis: A Randomized Clinical Trial

This study compares two methods used during full pulpotomy, a treatment for teeth with deep tooth decay that has exposed the dental pulp.

In the first method, the dentist removes the affected pulp tissue using a high-speed dental bur and then controls the bleeding using a sodium hypochlorite solution.

In the second method, the dentist also removes the affected pulp tissue using a high-speed dental bur, but a diode laser is used to control the bleeding. The laser may provide additional disinfection and achieve bleeding control more quickly.

After treatment, participants will be monitored to assess their level of pain relief. They will also return for follow-up visits at 6 months and 12 months, when dental X-rays will be taken to evaluate the success of the treatment.

研究概览

详细说明

Vital pulp therapy (VPT) is a minimally invasive treatment that aims to preserve the vitality and function of the dental pulp after exposure caused by deep caries. Compared with root canal treatment, VPT preserves the remaining healthy pulp tissue, allowing the tooth to maintain its natural defense mechanisms and reparative capacity. Full pulpotomy has become an accepted treatment option for permanent teeth with carious pulp exposure when the radicular pulp is considered healthy and capable of healing. Clinical studies have demonstrated high success rates for full pulpotomy in appropriately selected cases.

Successful pulpotomy depends on adequate removal of the inflamed coronal pulp tissue, effective control of pulpal bleeding, reduction of bacterial contamination, and placement of a suitable biocompatible pulp-capping material. Conventionally, hemostasis is achieved using sodium hypochlorite following removal of the coronal pulp tissue with a high-speed bur. Although this technique has demonstrated favorable outcomes, alternative methods that may improve hemostasis and enhance tissue healing continue to be investigated.

Diode lasers have been increasingly used in dentistry for soft tissue procedures because of their ability to provide precise tissue interaction, coagulation, and effective hemostasis. In addition to controlling bleeding, diode lasers have antimicrobial properties and may promote wound healing through biostimulatory effects that support tissue repair and reparative dentin formation. These characteristics suggest that diode laser-assisted pulpotomy may offer clinical advantages over the conventional technique.

Despite the increasing use of diode lasers in dentistry, clinical evidence regarding their use in full pulpotomy of permanent teeth with carious pulp exposure remains limited. Most published studies have evaluated diode laser pulpotomy in primary teeth or animal models, and randomized clinical trials in permanent teeth are lacking.

This randomized clinical trial is designed to compare diode laser-assisted full pulpotomy with the conventional full pulpotomy technique in permanent teeth with carious pulp exposure. In both study groups, the coronal pulp tissue will be removed using a conventional high-speed bur. In the control group, hemostasis will be achieved using sodium hypochlorite. In the experimental group, a diode laser will be used to achieve hemostasis following pulp removal. The same pulp-capping material and definitive restoration protocol will be used in both groups to ensure that the method of achieving hemostasis is the primary variable under investigation.

Participants will be evaluated for postoperative pain following treatment. Clinical and radiographic outcomes will be assessed at 6 and 12 months to determine treatment success. The study aims to determine whether diode laser-assisted full pulpotomy provides clinical and radiographic outcomes comparable to or better than those of the conventional technique.

研究类型

介入性

注册 (估计的)

70

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

      • Irbid、约旦、3030
        • Jordan University of Science and Technology

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

接受健康志愿者

是的

描述

Inclusion Criteria:

  • • Non -contributory medical history (SAI, II).

    • Premolar or Molar permanent tooth
    • Age range 10-60 years
    • Deep caries extending>= 2/3 of dentin or exposing the pulp on the radiograph
    • The tooth should give positive response to cold sensibility testing
    • Clinical diagnosis of irreversible pulpitis based on the symptoms and results of cold testing.
    • The tooth is restorable, probing pocket depth and mobility are within normal limits
    • No signs of pulpal necrosis including sinus tract or swelling

Exclusion Criteria:

  • Medically compromised patient.

    • Non-restorable tooth.
    • Signs of pulpal necrosis including sinus tract or swelling.
    • No enough bleeding after the pulpotomy procedure.
    • Inability to achieve hemostasis within 10 min after the pulpotomy.

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:三倍

武器和干预

参与者组/臂
干预/治疗
实验性的:Full pulpotomy using diode laser for hemostasis
Diode laser used after the full pulpotomy to achieve hemostasis following cutting of the pulp tissue.
The use of diode laser to achieve hemostasis after cutting the coronal part of the pulp tissue which is present in the tooth crown, down to the level of the canal orifices.
有源比较器:Full pulpotomy using sodium hypochlorite for hemostasis
The use of sodium hypochlorite to achieve hemostasis after cutting the pulp tissue to th level of root canal orifices
The use of Sodium hypochlorite to achieve hemostasis after full pulpotomy

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
Postoperative pain after pulpotomy
大体时间:One week after treatment
Postoperative pain will be assessed using an 11-point Numeric Rating Scale (NRS), where 0 indicates "no pain" and 10 indicates "the worst pain imaginable." Participants will record their pain intensity at the prespecified postoperative time points.
One week after treatment

次要结果测量

结果测量
措施说明
大体时间
Success of pulpotomy
大体时间:Six and 12 months after treatment
Clinical and radiographic success will be evaluated at the follow-up visits. Clinical success is defined as the absence of spontaneous pain, tenderness to percussion, swelling, sinus tract, pathological mobility, or other signs and symptoms indicating pulpal or periapical disease. Radiographic success is defined as the absence of periapical radiolucency, furcation involvement, external or internal root resorption, widening of the periodontal ligament space, or other radiographic evidence of treatment failure.
Six and 12 months after treatment

其他结果措施

结果测量
措施说明
大体时间
Tooth survival
大体时间:12 months after treatment
Tooth survival will be defined as the percentage of treated teeth remaining in the mouth and functioning without extraction during the follow-up period, regardless of the radiographic findings as far as the tooth is asymptomatic.
12 months after treatment

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。

调查人员

  • 学习椅:Nessrin Taha, PhD、Jordan University of Science and Technology

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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10月23日

初级完成 (估计的)

2027年6月1日

研究完成 (估计的)

2030年6月1日

研究注册日期

首次提交

2026年8月5日

首先提交符合 QC 标准的

2026年8月8日

首次发布 (实际的)

2026年8月13日

研究记录更新

最后更新发布 (实际的)

2026年8月13日

上次提交的符合 QC 标准的更新

2026年8月8日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

Individual participant data will not be shared because of institutional data-sharing policies and the need to protect participant confidentiality.

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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