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Bite Force and Occlusal Force Distribution Following Root Canal Treatment. (B-FORCE RCT)

2026年5月31日 更新者：Thanomsuk Jearanaiphaisarn、Chulalongkorn University

Changes in Bite Force and Occlusal Force Distribution Following Root Canal Treatment, Restoration, and Over Time: A Prospective Observational Study

Understanding the changes in bite force and occlusal force distribution in ETT is clinically important, as it can directly influence tooth prognosis, guide restorative treatment planning, and impact the long-term survival of the treated tooth. Therefore, this study aims to further explore changes and possible correlation in maximum bite force (MBF), occlusal force distribution and patients' subjective perception of chewing function of endodontically treated teeth after non-surgical root canal treatment, subsequent restoration, and during long-term follow-up, along with comparing to contralateral vital teeth.

Methods: Patients aged 20-60 years who underwent non-surgical root canal treatment at the Graduate Endodontic Clinic, Faculty of Dentistry, Chulalongkorn University, with the following teeth indicated for endodontic treatment. Measurements of maximum bite force (MBF) of ETT and contralateral vital teeth, relative occlusal force (ROF), and questionnaire responses, are performed at the following time points: before NS-RCT, 1 month after completion of NS-RCT (before doing restoration), 3 months after crown restoration, 1, 2 and 4 years after completion of NS-RCT.

Differences in MBF and ROF over time points within subjects and differences in MBF and ROF between ETT and their contralateral vital teeth were statistically analyzed.

研究概览

地位

尚未招聘

条件

研究类型

观察性的

注册 (估计的)

70

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

学习地点

  • 泰国
      • Bangkok、泰国、10330
        • Graduate Endodontic Clinic, Faculty of Dentistry, Chulalongkorn university
        • 接触：
        • 接触：
        • 首席研究员：
          • Prom Wongmaneerojn

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

  • 成人

接受健康志愿者

是的

取样方法

非概率样本

研究人群

Patients who underwent non-surgical root canal treatment at the Graduate Endodontic Clinic, Faculty of Dentistry, Chulalongkorn University

描述

Inclusion Criteria:

  • Premolars or molars diagnosed with pulp necrosis or previously initiate therapy with normal apical tissues, asymptomatic apical periodontitis, or chronic apical abscess without full coverage restoration.
  • Adequate remaining tooth structure for cuspal coverage restoration.
  • Presence of adjacent teeth and functional opposing natural teeth.
  • No analgesics drug effect at the time of investigation or not have taken analgesics 6 hours ago.

Exclusion Criteria:

  • Patients undergoing other dental treatments during the study period that may interfere with occlusion or bite force distribution, such as orthodontic treatment, jaw surgery, or full mouth restoration.
  • Received treatments that cause weakness of the jaw and facial muscles, such as botox injections.
  • History or symptoms of temporomandibular disorders (TMD)
  • Periodontal disease with second- or third-degree mobility
  • Teeth presenting crack lines extending into the pulp chamber floor or root canal orifices.

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

队列和干预

团体/队列
Endodontic patient
Patients aged 20-60 years undergoing non-surgical root canal treatment and subsequent restoration at the Graduate Endodontic Clinic, Faculty of Dentistry, Chulalongkorn University, with prospective assessment of bite force and occlusal force distribution over time.

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
Maximum bite force
大体时间：before NS-RCT, 1 month after completion of NS-RCT (before doing restoration), 3 months after crown restoration, 1, 2 and 4 years after completion of NS-RCT.
Maximum bite force of the endodontically treated tooth and its contralateral tooth in each patient will be measured using the FlexiForce ELF System and FlexiForce B201 sensor.
before NS-RCT, 1 month after completion of NS-RCT (before doing restoration), 3 months after crown restoration, 1, 2 and 4 years after completion of NS-RCT.
Relative occlusal force
大体时间：before NS-RCT, 1 month after completion of NS-RCT (before doing restoration), 3 months after crown restoration, 1, 2 and 4 years after completion of NS-RCT.
Relative Occlusal Force are measured with the T-Scan III system. A device will be inserted into the mouth of the patients, and they are instructed to bite firmly three times at the maximum cusp intersection position.
before NS-RCT, 1 month after completion of NS-RCT (before doing restoration), 3 months after crown restoration, 1, 2 and 4 years after completion of NS-RCT.

次要结果测量

结果测量
措施说明
大体时间
Patients' subjective perception of chewing function
大体时间：before NS-RCT, 1 month after completion of NS-RCT (before doing restoration), 3 months after crown restoration, 1, 2 and 4 years after completion of NS-RCT.
A questionnaire will be used to assess patients' subjective perceptions of chewing function, including preferred chewing side, frequency of hard food consumption, and parafunctional habits such as bruxism and clenching.
before NS-RCT, 1 month after completion of NS-RCT (before doing restoration), 3 months after crown restoration, 1, 2 and 4 years after completion of NS-RCT.

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

Chulalongkorn University

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6月8日

初级完成 (估计的)

2027年10月31日

研究完成 (估计的)

2030年10月31日

研究注册日期

首次提交

2026年5月31日

首先提交符合 QC 标准的

2026年5月31日

首次发布 (实际的)

2026年6月4日

研究记录更新

最后更新发布 (实际的)

2026年6月4日

上次提交的符合 QC 标准的更新

2026年5月31日

最后验证

2026年5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

  • HREC-DCU 2025-206

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

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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