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Full Pulpotomy in Permanent Teeth With Irreversible Pulpitis and Apical Periodontitis

2026年8月12日 更新者:Nessrin Taha、King Abdullah University Hospital

Outcome, Quality of Life and Patient Satisfaction After Full Pulpotomy in Permanent Teeth With Irreversible Pulpitis and Apical Periodontitis: A Prospective Exploratory Clinical Study.

This study will evaluate whether full pulpotomy can successfully treat mature permanent teeth with irreversible pulp inflammation and a periapical lesion. Full pulpotomy involves removing the inflamed pulp tissue from the crown of the tooth while preserving the healthy tissue inside the roots. The study will assess pain relief, patient satisfaction, and clinical and radiographic healing over time, including healing of the periapical lesion using dental X-rays and limited-field CBCT imaging. The findings may help determine whether full pulpotomy can provide a less invasive alternative to root canal treatment for selected teeth with periapical lesions.

研究概览

详细说明

This is a single-arm, prospective clinical study evaluating the effectiveness of full pulpotomy in mature permanent posterior teeth diagnosed with symptomatic or asymptomatic irreversible pulpitis and associated periapical radiolucency. The study will be conducted at the endodontic postgraduate, with a minimum target of 30 teeth in 30 patients recruited consecutively during the study period.

Eligible teeth will undergo clinical and radiographic assessment, including cold sensibility testing, percussion, palpation, periodontal assessment, and periapical radiography. Following local anesthesia and rubber dam isolation, caries will be completely removed and full pulpotomy will be performed to the level of the root canal orifices. The vitality of the remaining pulp tissue will be assessed clinically. Hemostasis will initially be attempted using sodium hypochlorite-moistened cotton pellets. A 980-nm diode laser will then be applied to the pulp tissue to assist hemostasis. Following adequate hemostasis, a calcium silicate-based pulp capping material will be placed over the pulp stumps, followed by a resin-modified glass ionomer liner and definitive resin composite restoration.

Teeth found to have complete pulpal necrosis or in which adequate hemostasis cannot be achieved will not proceed with the pulpotomy protocol and will receive appropriate endodontic treatment according to the clinical findings.

Clinical and radiographic follow-up will be performed at 6 and 12 months, with additional follow-up planned at 24 and 36 months. Periapical radiographs will be obtained during follow-up, and limited-field CBCT will be obtained immediately after treatment and at 12 months to assess changes in the periapical lesion. Treatment success will be determined based on the absence of clinical signs and symptoms and evidence of resolution or reduction of the periapical lesion. Radiographic healing will be assessed by comparing follow-up images with baseline postoperative images.

Patient-reported outcomes will include postoperative pain, analgesic intake, oral health-related quality of life, and patient satisfaction. Pain will be assessed before treatment and at 3 days and 1 week after treatment. Oral health-related quality of life and patient satisfaction will be assessed before treatment, at 1 week, and at 12 months.

The study will provide clinical and radiographic evidence regarding the feasibility and outcome of full pulpotomy in selected permanent teeth with irreversible pulpitis and periapical radiolucency. It will also assess patient-reported outcomes associated with this treatment approach and explore whether full pulpotomy may represent a less invasive alternative to conventional root canal treatment in appropriately selected cases.

研究类型

介入性

注册 (估计的)

30

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。

学习联系方式

  • 姓名:Nessrin Taha, DclinDent (Endo), PhD
  • 电话号码:+962776566110
  • 邮箱:n.taha@just.edu.jo

研究联系人备份

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).

    • Posterior permanent tooth (premolar, molar).
    • Age range 8-30 years
    • Deep caries extending into the inner quarter of dentin or exposing the pulp on the periapical radiograph
    • The tooth should give positive response to cold sensibility testing
    • Clinical diagnosis of symptomatic/asymptomatic irreversible pulpitis based on the symptoms, radiographic findings and results of cold testing
    • The tooth is restorable, probing pocket depth and mobility are within normal limits
    • Periapical radiograph demonstrates the presence of periapical lesion.

Exclusion Criteria:

  • Non-restorable tooth.
  • Signs of pulpal necrosis including sinus tract or swelling.
  • Evidence of necrotic tissue in one or all canals.
  • Profuse pulpal bleeding and inability to achieve hemostasis.

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:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Pulpotomy for permanent teeth with irreversible pulpitis and apical periodontitis.
Participants will receive full pulpotomy for permanent teeth with irreversible pulpitis and apical periodontitis. Treatment outcomes will be evaluated clinically and radiographically during follow-up.
Full pulpotomy will be performed in permanent teeth with irreversible pulpitis and apical periodontitis, with diode laser-assisted hemostasis and calcium silicate-based pulp capping. The intervention is distinguished by the treatment of teeth with radiographic evidence of apical periodontitis using a full pulpotomy approach rather than conventional root canal treatment.
其他名称:
  • 宫颈口腔切开术
  • Coronal 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
Success of pulpotomy
大体时间:6 and 12 months
Treatment success will be determined by the absence of clinical signs and symptoms of disease, together with radiographic evidence of healing or reduction of the periapical lesion.
6 and 12 months

次要结果测量

结果测量
措施说明
大体时间
Postoperative pain
大体时间:3 and 7 days after treatment
Postoperative pain will be assessed using a numerical rating scale from 0 to 10, where 0 represents no pain and 10 represents the most severe pain.
3 and 7 days after treatment

其他结果措施

结果测量
措施说明
大体时间
Oral health-related quality of life
大体时间:Before treatment, 1 week and 12 months after treatment
Oral health-related quality of life will be assessed using the Oral Health Impact Profile questionnaire modified for endodontic treatment.
Before treatment, 1 week and 12 months after treatment
Tooth Survival
大体时间:12, 24, and 36 months
Tooth survival will be assessed based on percentage of the treated teeth remains present and functional during the follow-up period.
12, 24, and 36 months

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, DClinDent, 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 (估计的)

2026年10月7日

初级完成 (估计的)

2028年10月1日

研究完成 (估计的)

2030年10月1日

研究注册日期

首次提交

2026年8月8日

首先提交符合 QC 标准的

2026年8月12日

首次发布 (实际的)

2026年8月17日

研究记录更新

最后更新发布 (实际的)

2026年8月17日

上次提交的符合 QC 标准的更新

2026年8月12日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 550/226

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 publicly due to institutional regulations regarding data access and participant confidentiality. Requests for access to study data may be considered by the Principal Investigator following publication of the study results, in accordance with university policies and applicable ethical requirements.

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

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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