An interventional study of Standard Needle Irrigation (SNI) and Passive Ultrasonic Irrigation (PUI in Antimicrobial Photodynamic Therapy, sponsored by Saglik Bilimleri Universitesi. Completed at 1 site in Turkey (Türkiye). Open to participants aged 15 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-10.
Sponsored by Saglik Bilimleri Universitesi · Not applicable, Interventional, and Supportive care
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.
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.
256 studies on the registry are indexed under Periapical Periodontitis; 65 are open to participants now.
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In this group, the activation of MB (Merck KgaA) was performed using a 30G NaviTip (Cermaked) with 1 activation cycle. The 30G NaviTip (Cermaked) was placed in the root canal 1 mm short of the working length and used with a 3-4 mm amplitude. The MB (Merck KgaA) solution was activated for 1 minute and renewed during the treatment
Procedure: Standard Needle Irrigation (SNI)
In this group, the activation of MB (Merck KgaA) was performed using Ultra X (Eighteeth, Changzhou, China) and a #25 ultrasonic endodontic tip (Eighteeth) at a frequency of 45 kHz. The ultrasonic endodontic tip was placed in the root canal 1 mm short of the working length and the MB (Merck KgaA) solution was activated for 1 minute. During the activation process, care was taken to ensure the ultrasonic endodontic tip moved freely within the canal, and the MB solution was renewed during the treatment.
Procedure: Passive Ultrasonic Irrigation (PUI
In this group, the activation of MB (Merck KgaA) was performed using a polymer EA tip (Dentsply, Tulsa, OK) with a 25.04 tip diameter, which was placed into the canal 2 mm short of the working length. The activation procedure was carried out for 1 minute using the EA sonic irrigation device at 10,000 cycles, and the MB (Merck KgaA) solution was renewed during the treatment.
Procedure: EndoActivator (EA)
In this group, the activation of MB (Merck KgaA) was performed using a polymer EDDY tip (VDW, Munich, Germany) with a 25.04 tip diameter and the Sonicmax sonic device (Maximum Dental Inc., Secaucus, NJ, USA) with one activation cycle. The EDDY (VDW) tip was placed in the canal 1 mm short of the working length and moved in a corono-apical direction at a frequency of 6 kHz and an amplitude of 5 mm for 1 minute to achieve MB activation. The MB (Merck KgaA) solution was renewed during the treatment.
Procedure: EDDY
Standard Needle Irrigation (SNI): Utilizes standard needle irrigation techniques for activating the antimicrobial solution within the root canal.
Passive Ultrasonic Irrigation (PUI): Employs ultrasonic energy to enhance the activation and effectiveness of the antimicrobial solution in the root canal.
EndoActivator (EA): Uses a sonic activation device to facilitate the distribution and activation of the antimicrobial solution in the root canal.
EDDY: Involves the use of a sonic activation device that operates at high frequency to activate the antimicrobial solution within the root canal. These descriptions focus on the general method and purpose of each intervention without delving into the specific procedural details already covered in the arm/group descriptions.
Reduction in Bacterial Load
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.
Time frame: Up to 6 months
Plan to share: Yes — We are currently undecided about sharing individual participant data (IPD) with other researchers. A decision will be made based on further discussions within the research team, ethical considerations, and the potential value of the data for future research. We will update this section once a final decision has been reached.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: From baseline to 6 months post-treatment
Access criteria: undecided
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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