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Outcome of Selective Caries Removal Performed by Undergraduate Students

2026年8月10日 更新者:Nessrin Taha、King Abdullah University Hospital

Selective Caries Removal in Deep Carious Lesions of Permanent Teeth by Undergraduate Dental Students: A Prospective Clinical Study

Deep tooth decay can sometimes reach very close to the nerve of a tooth. Traditionally, dentists may remove all of the decayed tooth tissue, but removing too much tissue can increase the risk of exposing or damaging the nerve.

This study is looking at a more conservative way of treating deep tooth decay called selective removal of tooth decay. Instead of removing all the affected tissue close to the nerve, some of it is carefully left in place to help protect the nerve and preserve the tooth.

We will compare two ways of doing this. In one group, the dentist will remove the decay until softer tooth tissue remains near the nerve. In the other group, the dentist will remove more of the decay until firmer, leathery tooth tissue remains.

About 100 patients with deep tooth decay in permanent teeth will take part in the study. The treatment will be provided by trained fifth-year dental students under supervision and using standardized procedures.

After treatment, patients will be asked about any pain at 1, 3, and 7 days. The treated teeth will also be checked clinically and with dental X-rays at 6 and 12 months.

The purpose of the study is to find out whether either approach provides better outcomes while preserving the health of the tooth. The results may help dentists choose the most appropriate and conservative way to treat deep tooth decay and may also help improve dental student training.

研究概览

详细说明

This is a prospective, randomized clinical study evaluating two approaches to selective caries removal (SCR) for the management of deep carious lesions in permanent teeth. The study will compare selective caries removal to soft dentine with selective caries removal to firm/leathery dentine. The aim is to determine whether the texture of the dentine left over the pulp influences clinical and radiographic treatment outcomes.

Following approval by the Institutional Review Board, eligible patients will be recruited from the dental teaching clinics at Jordan University of Science and Technology (JUST). Written informed consent will be obtained from all participants before enrollment. Approximately 100 patients will be included, with one tooth per patient. Participants will be randomly allocated in a 1:1 ratio to receive selective caries removal to either soft dentine or firm/leathery dentine.

Selective caries removal will be performed under rubber dam isolation according to a standardized clinical protocol. Soft dentine will be defined as soft, wet, easily deformable dentine that can be readily removed with a hand instrument. Firm/leathery dentine will be defined as drier, rubbery, less compressible dentine that provides moderate resistance to excavation. Following caries removal, the cavity will be disinfected and restored using a standardized adhesive restorative procedure.

Treatment will be performed by fifth-year undergraduate dental students under the supervision of experienced dental specialists. Supervisors will be calibrated before the study using standardized clinical cases, including clinical photographs, radiographs, and videos. Cases will be distributed among supervisors to promote consistent clinical supervision and standardization of treatment.

Baseline information, including patient and tooth characteristics, pain history, and caries risk, will be recorded. Postoperative pain will be assessed at 1, 3, and 7 days after treatment. Clinical and radiographic examinations will be performed at 6 and 12 months to evaluate the condition and treatment outcome of the treated teeth.

The study will assess whether selective caries removal to soft dentine provides outcomes comparable to or different from selective caries removal to firm/leathery dentine. The findings may help determine the most appropriate extent of caries removal for deep lesions and provide evidence to support conservative caries management in undergraduate dental education.

研究类型

介入性

注册 (估计的)

100

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
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

  • Patients in good general health (ASA I or II).
  • One permanent tooth with a deep carious lesion involving ≥ ¾ of the dentine on bitewing radiograph.
  • Positive response to cold and/or electric pulp testing.
  • Bite-wing radiographic evidence of a well-defined radiodense zone between the carious lesion and the pulp.

Exclusion Criteria:

  • Irreversible pulpitis
  • Need for post and core restoration
  • Non restorable teeth
  • Negative response to sensibility testing
  • Inability to isolate the tooth via rubber dam

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:Selective craies removal to soft dentine
Dental caries will be cleaned from peripheries and soft dentine will be left over the pulpal wall
Selective removal of carious dentine until soft dentine remains over the pulp, followed by standardized cavity disinfection and adhesive restoration.
有源比较器:Selective caries removal to firm dentine
Dental caries will be cleaned from peripheries and firm dentine will be left over the pulpal wall
Selective removal of carious dentine until firm/leathery dentine remains over the pulp, followed by standardized cavity disinfection and adhesive restoration.

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
大体时间:6, 12, 24, 36 months
Treatment success will be assessed based on the clinical and radiographic condition of the treated tooth. Clinical success will include absence of spontaneous pain, tenderness to percussion, swelling, sinus tract, or other signs of pulpal or periapical disease. Radiographic success will be defined by tooth vitality and response to sensibility testing and absence of periapical pathology on follow-up radiographs.
6, 12, 24, 36 months

次要结果测量

结果测量
措施说明
大体时间
Postopertive pain
大体时间:1, 3, 7 days postoperative
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. Participants will report their pain intensity following treatment, and any analgesic use during the postoperative period will also be recorded.
1, 3, 7 days postoperative
Tooth survival
大体时间:12, 24, 36 months
Tooth survival will be assessed by determining whether the treated tooth remains present and functional during the follow-up period. Tooth survival will be defined as retention of the treated tooth without extraction. The need for additional endodontic treatment or other major intervention will also be recorded.
12, 24, 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 (实际的)

2025年11月1日

初级完成 (估计的)

2027年12月1日

研究完成 (估计的)

2029年11月1日

研究注册日期

首次提交

2026年8月10日

首先提交符合 QC 标准的

2026年8月10日

首次发布 (实际的)

2026年8月14日

研究记录更新

最后更新发布 (实际的)

2026年8月14日

上次提交的符合 QC 标准的更新

2026年8月10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

  • 494/2025

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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