Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634745
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
The Effect of Antimicrobial Photodynamic Therapy on the Success of Root Canal Treatment
Sponsor:
None
Organization:
None
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 MBs 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
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 MBs 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None