Clinical trial NCT06634745: The Effect of Antimicrobial Photodynamic Therapy on the Success of Root Canal Treatment
Official title: Evaluation of the Effectiveness of Antimicrobial Photodynamic Therapy Using Different Irrigation Activation Techniques in Teeth With Apical Periodontitis: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antimicrobial Photodynamic Therapy
Keywords: Antimicrobial photodynamic therapy
Methylene blue
Apical periodontitis
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a randomized, parallel-group clinical trial evaluating the effectiveness of antimicrobial photodynamic therapy (aPDT) using different irrigation activation techniques in teeth with apical periodontitis. Sixty patients with single-rooted, single-canal teeth were included. Participants were randomly assigned to four groups: aPDT with standard needle irrigation (SII), aPDT with Endoactivator, aPDT with passive ultrasonic irrigation (PUI), and aPDT with EDDY. All groups received aPDT using methylene blue, following standard endodontic procedures. The primary outcome was the efficacy of microbial reduction in the root canal system. Secondary outcomes included lesion healing, postoperative pain, and discoloration potential. Data were analyzed to compare the effectiveness of different techniques. The null hypothesis was that there would be no significant difference among the groups in terms of lesion healing, postoperative pain, and discoloration potential.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Reduction in Bacterial Load
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: University of Health Sciences Gulhane
Study officials:
affiliation: University of Health Sciences Gülhane
name: Özge Hür Şahin, DDS
role: STUDY_DIRECTOR
affiliation: University of Health Sciences Gülhane
name: Zeliha Uğur Aydın, Assoc. Prof.
role: STUDY_CHAIR
References:
citation: Asnaashari M, Mojahedi SM, Asadi Z, Azari-Marhabi S, Maleki A. A comparison of the antibacterial activity of the two methods of photodynamic therapy (using diode laser 810 nm and LED lamp 630 nm) against Enterococcus faecalis in extracted human anterior teeth. Photodiagnosis Photodyn Ther. 2016 Mar;13:233-237. doi: 10.1016/j.pdpdt.2015.07.171. Epub 2015 Aug 1.
citation: Er Karaoglu G, Ugur Ydin Z, Erdonmez D, Gol C, Durmus M. Efficacy of antimicrobial photodynamic therapy administered using methylene blue, toluidine blue and tetra 2-mercaptopyridine substituted zinc phthalocyanine in root canals contaminated with Enterococcusaecalis. Photodiagnosis Photodyn Ther. 2020 Dec;32:102038. doi: 10.1016/j.pdpdt.2020.102038. Epub 2020 Oct 1.
citation: da Silva CC, Chaves Junior SP, Pereira GLD, Fontes KBFDC, Antunes LAA, Povoa HCC, Antunes LS, Iorio NLPP. Antimicrobial Photodynamic Therapy Associated with Conventional Endodontic Treatment: A Clinical and Molecular Microbiological Study. Photochem Photobiol. 2018 Mar;94(2):351-356. doi: 10.1111/php.12869. Epub 2018 Jan 19.