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临床试验/NCT06634745
NCT06634745已完成不适用

Evaluation of the Effectiveness of Antimicrobial Photodynamic Therapy Using Different Irrigation Activation Techniques in Teeth With Apical Periodontitis: A Randomized Controlled Clinical Trial

Saglik Bilimleri Universitesi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年6月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Reduction in Bacterial Load

研究概览

简要总结

The decontamination of the root canal system from pathological microflora is essential for the success of endodontic treatment. Mechanical instrumentation and irrigation solutions, known as the chemomechanical process, are typically used for this purpose. However, due to the complex anatomy of teeth, residual microorganisms can remain, potentially affecting treatment success and weakening dentin walls. This has led to the development of more effective irrigation and disinfection systems.

Antimicrobial photodynamic therapy (aPDT) has emerged as a promising adjunct to traditional methods. aPDT is used to eliminate resistant microorganisms in various medical fields, including dentistry, and has been shown to effectively destroy oral bacteria in both planktonic and biofilm forms. However, aPDT is not a replacement for traditional endodontic procedures but can be used as an adjunct in root canal disinfection.

aPDT works through the presence of a photosensitizer, a radiation source with a sufficient wavelength, and oxygen, producing reactive oxygen species (ROS) that have a bactericidal effect. Methylene blue (MB) is a common photosensitizer, but it can cause tooth discoloration and is difficult to remove. Alternatives to MB are being sought.

Different activation techniques, such as passive ultrasonic irrigation (PUI) and sonic activation systems (SAS), have been developed to enhance the effectiveness of irrigation solutions. Studies have shown that PUI and SAS have similar effectiveness in traditional endodontic irrigation. Enterococcus faecalis is a particularly resistant bacterium involved in endodontic infections. While MB's effectiveness against E. faecalis is documented, there is a lack of studies comparing its effectiveness with ultrasonic and sonic systems in necrotic and periapical lesion teeth. There is also limited research on the discoloration potential and postoperative pain of MB when used with various activation systems. The study hypothesizes that there will be no significant difference in lesion healing, postoperative pain, and discoloration potential with different activation systems using aPDT.

详细描述

It is well known that the decontamination of the root canal system from pathological microflora is a prerequisite for the success of endodontic treatment. In addition to mechanical instrumentation, various irrigation solutions and intracanal medications are used to decontaminate the root canal from microorganisms. The combined use of mechanical instrumentation and irrigation solutions is referred to as the chemomechanical process. However, due to the complex anatomy of the tooth structure, such as lateral canals, isthmuses, dentinal tubules, and accessory canals, residual microorganisms may remain despite the completion of the chemomechanical process. This can negatively affect the success of the treatment. Additionally, it is noted that the dentin walls may weaken as a result of chemomechanical preparation. Therefore, researchers often emphasize the need for more effective irrigation and disinfection systems.

Recently, the application of antimicrobial photodynamic therapy (aPDT) has been shown to be a promising addition to traditional methods. Today, aPDT is used to eliminate resistant microorganisms in cancer treatment, macular degeneration, arterial plaque, arthritis treatment, and dentistry. aPDT has been reported to effectively destroy oral bacteria present in both planktonic and biofilm forms. However, researchers state that aPDT cannot replace traditional endodontic procedures but can be used as an adjunct in root canal disinfection.

The working principle of aPDT is based on the presence of a specific photosensitizer, a radiation source with a sufficient wavelength, and the presence of oxygen in the environment. As a result of the reaction caused by aPDT, reactive oxygen species (ROS) such as singlet oxygen and free radicals are produced, leading to a bactericidal effect. Thus, a wide range of microorganisms can be eliminated without encountering the resistance problem of current bacterial strains. Additionally, aPDT offers various advantages due to its repeatability, low toxicity, and minimally invasive approach.

Various photosensitizers and light sources with different wavelengths are available for use in aPDT. One of the most widely used photosensitizers in the literature is methylene blue (MB) from the phenothiazine salts group. However, it is known that MB is difficult to remove after application and can cause tooth discoloration. Therefore, alternative photosensitizers to MB are being sought. Today, the antimicrobial efficacy of MB is well recognized. Due to the low absorption exhibited by phenothiazine dyes, which are among the most commonly used photosensitizers, multiple applications are required for a high drug dose and effective treatment outcome. The effectiveness of solutions is not solely dependent on the properties of the solution but also varies with the method used. Although the traditional needle irrigation method (GII) is still in use, its effectiveness is limited. Another method, manual dynamic activation (MDA), involves creating a hydrodynamic force in the irrigation solutions by moving a gutta-percha that fits well into a shaped root canal in a corono-apical direction at the working length. This method is frequently used as it does not require additional materials.

With technological advancements, different methods have been developed to enhance the effectiveness of solutions. The passive ultrasonic irrigation (PUI) method shows effectiveness by causing acoustic streaming through the vibration it generates. The solution is activated during the application without any contact with the root canal walls. Another method, the sonic activation system (SAS), has been used in endodontics for years and has proven its effectiveness. Several SAS devices from different manufacturers have been developed. One commonly used device, Endoactivator, has a polymer tip and works through sinusoidal oscillation. Another widely used device, EDDY (VDW, Munich, Germany), oscillates at 5000-6000 Hz, causing three-dimensional movement in the root canal and triggering cavitation and acoustic streaming. Studies have shown that the effectiveness of PUI and SAS on traditional endodontic irrigation solutions is similar. Enterococcus faecalis (E. faecalis) is a gram-positive facultative bacterium. It is among the most resistant strains involved in the development of anaerobic and endodontic infections. Although detailed literature reviews have shown studies proving the effectiveness of MB on E. faecalis bacteria, there is no study comparing the effectiveness of MB solution in necrotic and periapical lesion teeth using ultrasonic and sonic systems. It has been found that there is no comprehensive study in the literature comparing the discoloration potential and postoperative pain of MB applied with various activation systems. The null hypothesis of the study is that there will be no significant difference in lesion healing, postoperative pain, and discoloration potential with different activation systems using aPDT.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

Participants: The participants in this study were blinded to their treatment allocation. They did not know whether they were receiving antimicrobial photodynamic therapy (aPDT) with standard needle irrigation, EDDY sonic activation system, passive ultrasonic irrigation, or Endoactivator sonic activation system.

入排标准

年龄范围
15 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Teeth that had not undergone previous root canal treatment.
  • Teeth with a single root and a single canal.
  • Teeth with apical periodontitis.
  • Teeth with periodontal lesion size less than 5 mm.
  • Teeth without sinus tract or acute apical abscess.
  • Patients without systemic diseases.
  • Patients not pregnant.
  • Patients who volunteered to participate in the study.
  • Patients who agreed to attend follow-up sessions.

排除标准

  • Patients using medications such as antihypertensives or antidiabetics that could affect root canal treatment outcomes.
  • Patients using corticosteroids or antibiotics.
  • Patients with acute pain or extraoral swelling.
  • Patients with a history of sinus tract or acute apical abscess.
  • Patients with systemic diseases.
  • Patients who are pregnant.

结局指标

主要结局

Reduction in Bacterial Load

时间窗: Up to 6 months

This study aims to evaluate the effectiveness of antimicrobial photodynamic therapy (aPDT) using different irrigation activation techniques in teeth with apical periodontitis. The study will be conducted as a randomized, parallel-group clinical trial with four intervention groups: Standard Needle Irrigation (SNI), Passive Ultrasonic Irrigation (PUI), EndoActivator (EA), and EDDY.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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