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临床试验/NCT07341451
NCT07341451已完成不适用

Novel Experimental Methods to Measure Apically Extruded Debris and Solutions During Root Canal Intstrumantation, an Invitro Study

Fatma Selenay Ucas Yildiz1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年9月29日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Radiographic Area of Apically Extruded Debris

研究概览

简要总结

Endodontic treatment occupies a critical role in dentistry, serving to prolong the longevity of teeth within the oral cavity and prevent early tooth loss. This treatment is particularly indicated in cases where the pulp tissue is infected or has suffered damage. The primary objective of endodontic treatment is to clean the infected pulp tissue, shape the root canals, and adequately fill these spaces to preserve the functionality of the tooth. A successful endodontic procedure is essential not only for ensuring the longevity of the tooth but also for delaying resorption in surrounding tissues. Furthermore, it allows the patient to maintain masticatory function without losing proprioceptive sensation, which is a key indicator of the treatment's success.

During root canal instrumentation, there is a risk of necrotic debris, microorganisms, and dentin particles being displaced through the apical foramen into the periapical tissue. This displacement can increase the risk of infection and lead to postoperative complications. The preservation of the apical foramen is one of the most critical stages in the endodontic treatment process. Materials that extrude beyond the apical foramen can cause irritation and inflammation in the alveolar bone. This situation may exacerbate postoperative pain and discomfort, negatively affecting the patient's satisfaction with the treatment. Additionally, such displacements can compromise the overall success of the procedure by increasing the risk of reinfection. Therefore, preventing these displacements during root canal shaping is a factor that directly influences the success of the treatment.

In the literature, precision scales are commonly used to measure the materials displaced from the apex. However, there are discrepancies regarding the reliability of these scales, particularly concerning their measurement accuracy for very small quantities. It has been observed that these precision scales may not provide sufficient accuracy in certain situations, making it challenging to accurately determine the amount of extruded materials. This issue poses a significant barrier to the assessment of endodontic treatment outcomes. Consequently, there is a need for the development of existing measurement methods and the exploration of alternative approaches. The integration of new technologies for measuring the quantity of extruded materials could enhance the understanding and management of treatment processes.

In this context, the primary aim of this research is to develop new methods for the more accurate and reliable measurement of materials displaced from the apex. Novel measurement techniques will allow for a more precise determination of the quantity of extruded materials, thereby enhancing the efficacy of endodontic treatment processes. Furthermore, this research aims to contribute to the reduction of postoperative complications and improve patient satisfaction during the treatment process. Ultimately, innovative approaches of this nature are of great importance for the success of endodontic treatments and patient satisfaction. Research in the field of endodontics will not only guide clinical practices but also make significant contributions to the scientific literature. Such innovations will assist in the development of future treatment protocols and the enhancement of patient care.

详细描述

Detailed Description

The purpose of this study is to develop alternative and reliable measurement methods for quantifying solid and liquid substances unintentionally extruded from the apical foramen during endodontic treatment with higher precision. The investigators will assess the limitations and applicability of the proposed methods, which are expected to contribute to future treatment improvements. The study also aims to evaluate the potential of these methods to reduce postoperative pain and infection risks in clinical practice. This research is anticipated to make significant contributions to enhancing the effectiveness and reliability of endodontic treatment processes.

This in vitro study was designed to evaluate the amount of apical extrusion (debris and irrigation solution overflow) occurring during root canal treatment. A total of 80 extracted human lower premolar teeth, selected according to predefined criteria, were used. The primary objective was to compare the effects of two different rotary file systems-ProTaper Gold and ProTaper Next-on the amount of apical overflow.

Selection and Preparation of Specimens

The specimens consisted of extracted lower premolars with fully developed roots, a single canal, a single apical foramen, moderate root inclination, and no previous endodontic treatment. Root canal inclination angles were determined using the Schneider method, and only specimens with inclinations between 5° and 20° were included to better simulate clinical conditions. Teeth with multiple apical foramina, cracks, or fractures were excluded following examination under magnification. The criteria of single root and single canal were verified radiographically.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

盲法说明

During root canal instrumentation, the operator could not observe the amount of extruded debris or irrigant. Radiographic evaluation of extrusion was performed afterwards. Although the assessor was aware of group allocation, the extrusion itself was not visible during instrumentation, thus minimizing bias.

入排标准

性别
All
接受健康志愿者

入选标准

  • Extracted human mandibular premolars with fully formed apices Single straight root canal confirmed radiographically No resorption, fracture, or previous endodontic treatment No caries or restorations extending into the root canal

排除标准

  • Teeth with multiple canals, severe curvature (>20°) Immature apices or open apex External or internal root resorption Presence of root fractures, cracks, or structural anomalies Teeth with previous endodontic instrumentation or obturation Teeth with extensive coronal defects that compromise standardization

研究组 & 干预措施

ProTaper Gold - Debris Extrusion

Experimental

Extracted mandibular premolars shaped with ProTaper Gold rotary files.

Apical extrusion of debris measured using chromium-cobalt particles.

干预措施: ProTaper Gold Rotary File System (Device)

ProTaper Next - Debris Extrusion

Experimental

Extracted mandibular premolars shaped with ProTaper Next rotary files.

Apical extrusion of debris measured using chromium-cobalt particles.

干预措施: ProTaper Next Rotary File System (Device)

ProTaper Gold - Irrigant Extrusion

Experimental

Extracted mandibular premolars shaped with ProTaper Gold rotary files.

Apical extrusion of irrigant measured using barium sulfate-enhanced NaOCl.

干预措施: ProTaper Gold Rotary File System (Device)

ProTaper Next - Irrigant Extrusion

Experimental

Extracted mandibular premolars shaped with ProTaper Next rotary files.

Apical extrusion of irrigant measured using barium sulfate-enhanced NaOCl

干预措施: ProTaper Next Rotary File System (Device)

结局指标

主要结局

Radiographic Area of Apically Extruded Debris

时间窗: Baseline

During the single experimental session of root canal instrumentation and irrigation

Radiographic Area of Apically Extruded Irrigant

时间窗: Baseline

Quantification of apically extruded irrigant using barium sulfate-enhanced NaOCl/EDTA solutions. After instrumentation, standardized digital radiographs are analyzed in ImageJ to measure the radiopaque area and spread pattern of the extruded irrigant on the sponge background.

次要结局

未报告次要终点

研究者

发起方
Fatma Selenay Ucas Yildiz
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Fatma Selenay Ucas Yildiz

Research Assistant and Principal Investigator

Necmettin Erbakan University

研究点 (1)

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