NCT06931678

Photodynamic Therapy in Root Canal Treatment of T2DM Patients: Microbiome Analysis Via Next-Gen Sequencing

Evaluation of the Effectiveness of Root Canal Treatment Performed Using Photodynamic Therapy in Teeth With Apical Periodontitis in Patients With Type 2 Diabetes Through Next-Generation Sequencing Microbiome Analysis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Saglik Bilimleri Universitesi · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Type 2 Diabetes Mellitus (T2DM)
• Necrotic Pulp
• Apical Periodontitis

Interventions

Type	Name	Description
PROCEDURE	aPDT	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.

Timeline

• Start date: 2024-10-21
• Primary completion: 2025-04-07
• Completion: 2025-04-07
• First posted: 2025-04-17
• Last updated: 2025-04-17

Locations

1 site across 1 country: Turkey (Türkiye)