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Effect of Different Root Canal Preparation Sizes and Remaining Tooth Structure on the Survival of Endodontically Treated Mandibular Molars

2026年5月12日 更新者:Sıla Nur Usta、Saglik Bilimleri Universitesi

Investigation of the Effect of Different Root Canal Preparation Sizes and Remaining Tooth Structure on the Survival of Endodontically Treated Mandibular Molars: A Randomized Clinical Trial

Teeth that have undergone endodontic treatment are biomechanically weakened compared to vital teeth due to factors such as extensive carious lesions, previous restorations, loss of marginal ridges and pericervical dentin, and hard tissue removal during access cavity preparation and root canal instrumentation. Additionally, the quantity and quality of the remaining coronal tooth structure, the presence of marginal ridges, the ferrule effect, and the integrity of pericervical dentin directly influence both fracture resistance and the long-term success of restorations.

Following endodontic access cavity preparation, the fracture resistance of the tooth decreases by approximately 5%. This reduction increases to around 20-30% in the case of unilateral marginal ridge loss (mesio-occlusal [MO] or disto-occlusal [DO] cavities), and can reach up to 63% when both marginal ridges are lost (mesio-occluso-distal [MOD] cavities). This condition may lead to cusp deflection under occlusal forces and, particularly in the absence of appropriate post-endodontic restoration, may result in failures such as vertical root fractures.

It has been reported that, after caries removal and access cavity preparation, the amount of remaining sound coronal tooth structure may play an important role in determining the extent of mechanical preparation during treatment. The goal of mechanical preparation of the root canal system is to remove infected dentin and biofilm as much as possible and to create a continuously tapered canal shape that allows effective delivery of irrigants to the apical region. Although conventional preparation principles may provide higher levels of disinfection, they have been associated with reduced tooth strength, particularly due to the loss of resistance in the pericervical area. This has led to the development of more conservative root canal preparation strategies using instruments with smaller apical sizes and tapers.

Previous studies investigating the relationship between preparation size and fracture resistance have shown considerable heterogeneity. Moreover, the predominantly in vitro nature of these studies limits their ability to accurately simulate clinical conditions. In addition, factors such as the amount of remaining tooth structure after treatment and the effectiveness of the final restoration are often overlooked. Therefore, it is important to support in vitro findings with clinical studies. To date, there is no long-term clinical study in the literature evaluating the combined effects of conventional and conservative preparation strategies on clinical survival and periodontal health in teeth with varying degrees of coronal tissue loss.

The aim of this study is to clinically and radiographically evaluate the survival of mandibular molars with different amounts of remaining tooth structure (O, MO/DO, and MOD) following conventional and conservative root canal preparation. The null hypothesis is that different preparation strategies and the amount of remaining tooth structure have a similar effect on tooth survival.

研究概览

详细说明

The sample size calculation was performed using G*Power 3.1.9.2 software, based on a significance level of 5% (α = 0.05), an effect size of 0.4921, and a statistical power of 95% (1-β = 0.80). The analysis indicated that a minimum of 10 students per group would be required to detect a statistically significant effect.

3.2. Clinical Methodology Within the scope of this study, patients who applied to the University of Health Sciences, Gülhane Faculty of Dentistry, Department of Endodontics with complaints of pain in the mandibular first and second molar teeth will be evaluated based on the following inclusion and exclusion criteria.

3.2.1. Clinical Examination Clinical examinations will be performed to diagnose irreversible pulpitis. Data regarding pain onset, duration, spontaneity, nocturnal increases, and sensitivity to thermal stimuli (hot/cold) will be recorded. Pain will be evaluated using the Visual Analog Scale (VAS); only patients with moderate-to-severe (symptomatic) pain will be included.

Tooth vitality will be assessed via Electric Pulp Test (EPT) and cold tests. To ensure reliability, tests will be also applied to the contralateral tooth in the opposite arch. Teeth responding positively will be included. However, as partial necrosis can occur in multi-rooted teeth, patients will be excluded if no pulpal bleeding will be observed following access cavity preparation. Percussion and palpation sensitivity will be also evaluated.

3.2.2. Radiographic Examination Radiographic examinations will be conducted using the parallel technique with a periapical radiograph. In this technique, the image receptor is positioned parallel to the long axis of the tooth, and the X-ray beam is directed perpendicularly. This minimizes magnification and distortion, providing the most accurate anatomical view and allowing for standardized comparisons of pre- and post-treatment records.

Patients with a Periapical Index (PAI) score of <3 will be included. All images will be saved within the university's imaging system.

3.2.3. Endodontic Treatment Protocol Patients will be inferior alveolar nerve block anesthesia using 80mg/2mL+0.02mg/2mL articaine hydrochloride (Maxicaine Forte). Success will bedefined as significant lip numbness within 15 minutes. Following rubber dam isolation, tooth surfaces will be disinfected with 30% H2O2 for 30 seconds, followed by 2.5% NaOCl, which will be then inactivated with 5% sodium thiosulfate.

Caries will be removed using high-speed diamond round burs and low-speed tungsten carbide burs. Access cavities will be prepared using sterile diamond fissure burs and safe-ended burs (Endo-Z).

Teeth will be assigned to groups based on the remaining dentin walls:

Group 1: Occlusal cavity (4 walls)

Group 2: MO/OD cavity (3 walls)

Group 3: MOD cavity (2 walls)

Cusp thickness will be measured with a periodontal probe; only cases with a wall thickness of ≥1.5-2 mm were included for biomechanical safety. Patients in each group will be then randomized into two subgroups based on the file system: ProTaper Gold or TruNatomy.

Working length (WL) will be determined using a #10 K-file and an apex locator (set 1 mm short of the "0.0" point) and will be onfirmed radiographically.

ProTaper Gold Group: Shaped using Sx-S1-S2-F1-F2-F3 files in rotation. Mesial canals will be enlarged to F2, distal to F3.

TruNatomy Group: Shaped using Orifice Shaper, Glider, Small, Prime, and Medium files in rotation.

Irrigation will be performed between file changes using 2.5% NaOCl (15 mL total) via a side-vented needle (Irriflex). Final irrigation consisted of 3 mL each of: 2.5% NaOCl → Distilled water → 17% EDTA → Distilled water → 2.5% NaOCl. The final NaOCl and EDTA will be activated using the EndoActivator (3 cycles of 30 seconds).

Canals will be dried with paper points and filled with Dia-Proseal resin sealer and gutta-percha using the lateral condensation technique. Proper fit will be ensured using ProTaper Gold or TruNatomy Conform Gutta Percha. Post-obturation radiographs will be taken using the parallel technique.

Restoration and Follow-up The final restoration will be completed using GC G-ænial Posterior composite resin.

研究类型

介入性

注册 (估计的)

60

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

  • 成人

接受健康志愿者

是的

描述

Inclusion Criteria: Patients with mandibular molar teeth diagnosed with symptomatic irreversible pulpitis according to the pulp disease classification recommended by the American Association of Endodontists

Patients with active caries in the relevant tooth that would create O, MO/OD, or MOD type cavitations.

Patients with periodontally healthy teeth (Grade I mobility or <4 mm pocket depth).

Patients with no systemic diseases (ASA I or II).

Patients between the ages of 18-60.

Teeth where rubber dam isolation could be achieved.

Cases where the remaining sound tooth structure allowed for a direct composite restoration.

Exclusion Criteria:Teeth with non-vital pulp and/or observable periapical lesions.

Teeth that were not periodontally healthy (Grade II/III mobility or >3 mm pocket depth).

Teeth with complex root canal anatomy (curved canals, C-shaped canals, calcified/obstructed canals, etc.).

Patients with systemic diseases, or those who were pregnant or breastfeeding.

Patients with parafunctional habits such as bruxism.

Teeth without an opposing tooth in the maxillary arch.

Teeth that could not be restored due to advanced crown destruction or those with existing prosthetic restorations.

Patients whose endodontic treatment had already been initiated elsewhere.

Patients who experienced complications during the treatment procedure.

-

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:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:ProTaper Gold
Mandibular molar teeth of patients will be treated using ProTaper Gold rotary file sytem.
Patients will be treated endodontically using Protaper Gold rotary file system
其他名称:
  • File system
实验性的:TruNatomy
Mandibular molar teeth of patients will be treated using TruNatomy rotary file sytem.
TruNatomy file system

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
Periapical healing
大体时间:at 6, 12 and 18 months
Evaluation of the periapical healing based on the PAI score system. The system provides an ordinal scale of 5 scores ranging from 1 (healthy) to 5 (severe periodontitis with exacerbating features.
at 6, 12 and 18 months

次要结果测量

结果测量
措施说明
大体时间
Restoration survival
大体时间:6, 12 and 18 months
Restoration quality was assessed using USPHS criteria. This criteria includes parameters as marginal adaptation, anatomic form, secondary caries, retantion, hypersensitivity, and color match.
6, 12 and 18 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。

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)

2024年1月1日

初级完成 (实际的)

2025年8月1日

研究完成 (估计的)

2026年8月1日

研究注册日期

首次提交

2026年4月30日

首先提交符合 QC 标准的

2026年5月12日

首次发布 (实际的)

2026年5月13日

研究记录更新

最后更新发布 (实际的)

2026年5月13日

上次提交的符合 QC 标准的更新

2026年5月12日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • SBU-GFOD-ENDO-SILANURUSTA-003
  • 2024/075 (其他赠款/资助编号:University of Health Sciences)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Within the scope of the necessity of protecting the individual information of the students and patients, it is considered that the recorded data will not be shared.

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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