This clinical study investigates the effectiveness of antimicrobial photodynamic therapy (aPDT) as an additional disinfection method in root canal treatment of patients with Type 2 Diabetes Mellitus (T2DM) who have apical periodontitis (AP). T2DM is known to negatively impact the healing of periapical tissues due to impaired immune response. In this study, methylene blue is used as a photosensitizer, activated by a specific wavelength of light to eliminate residual bacteria that are difficult to reach with conventional cleaning methods. The bacterial load and changes in the root canal microbiome will be analyzed using next-generation sequencing (NGS) of the 16S rRNA gene. The goal is to assess the microbial elimination and healing of periapical lesions, and to improve treatment outcomes in diabetic patients.
Systemic diseases such as Type 2 Diabetes Mellitus (T2DM) are known to influence both the etiology and healing process of endodontic diseases. T2DM is characterized by chronic hyperglycemia and impaired immune responses, which may negatively affect the resolution of periapical inflammation following root canal treatment. Apical periodontitis (AP) is a common endodontic pathology, often resulting from bacterial infection in the root canal system. The prevalence and severity of AP are higher in diabetic patients, and studies have shown reduced survival rates of endodontically treated teeth in this population. The primary aim of this study is to evaluate the effectiveness of antimicrobial photodynamic therapy (aPDT) as an adjunctive disinfection method following conventional root canal preparation in T2DM patients with AP. aPDT utilizes a photosensitizer-methylene blue in this study-that, when activated by light of a specific wavelength, generates reactive oxygen species to eliminate residual microorganisms in complex anatomical areas such as isthmuses and lateral canals. The study will utilize next-generation sequencing (NGS) of the 16S rRNA gene to assess bacterial diversity and quantify microbial elimination before and after aPDT application. The healing response of periapical lesions will also be monitored. The findings aim to contribute to improved treatment strategies and outcomes for endodontic therapy in systemically compromised patients, particularly those with T2DM.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
This intervention involves the application of antimicrobial photodynamic therapy (aPDT) using methylene blue as a photosensitizer, followed by activation with a light source at an appropriate wavelength. The protocol is applied after conventional root canal preparation and irrigation. The aPDT protocol is standardized and performed in both medically healthy patients and patients with Type 2 Diabetes Mellitus (T2DM), allowing comparison of microbiological and clinical outcomes between the two groups. This intervention aims to enhance root canal disinfection, particularly in anatomically complex areas that are difficult to reach with traditional methods.
Gulhane Faculty of Dentistry, University of Health Sciences
Ankara, Etlik, Turkey (Türkiye)
1. Radiographic Assessment of Lesion Healing at 6 months
Lesion healing will be evaluated using periapical radiographs with the parallel technique, and the Periapical Index (PAI) will be used for the assessment of lesion healing.
Time frame: Postoperative an avarage of 6 months
Change in Pain Level at day 1, day 3, and day 7 Post-Treatment
Pain levels will be assessed using the Numerical Rating Scale (NRS), ranging from 0 (no pain) to 100 (worst pain), measured at day 1, day 3, and day 7 post-procedure.
Time frame: Post-Treatment at day 1, day 3, and day 7
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.