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

NCT ID: NCT06931678

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-21
• Study Completion Date: 2025-04-07

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Necrotic pulped, mature teeth with apical periodontitis

This study arm involves the application of antimicrobial photodynamic therapy (aPDT) as an adjunct to conventional root canal treatment in mature permanent teeth diagnosed with apical periodontitis and pulp necrosis. Following standard chemomechanical preparation, methylene blue is used as the photosensitizer, activated by a specific wavelength light source to enhance disinfection of the root canal system.

Group Type: EXPERIMENTAL

aPDT

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• • Individuals aged between 18 and 65 years

• Voluntarily agree to participate in the study and attend follow-up sessions
• Systemically healthy individuals (no systemic diseases)
• Not taking antihypertensive or antidiabetic medications
• Not pregnant
• No use of corticosteroids or antibiotics within the last 3 months
• No history of smoking
• No acute pain or extraoral swelling
• No sinus tract or acute apical abscess
• Presence of a periapical lesion with a Periapical Index (PAI) score ≥ 3
• Presence of a mature, single-rooted permanent tooth with completed root development

Exclusion Criteria

• • Severe periodontal disease

• Internal or external root resorption
• Open apex (immature root development)
• Suspected vertical root fracture
• Non-restorable teeth
• Teeth with previous root canal treatment
• Presence of developmental dental anomalies

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Health Institutes of Turkey

OTHER_GOV

Sponsor Role: collaborator

Saglik Bilimleri Universitesi

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hulde Korucu, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Health Sciences Gülhane Faculty of Dentistry Department of Endodontics

Locations

Gulhane Faculty of Dentistry, University of Health Sciences

Ankara, Etlik, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

37379

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HKORUCU2

Identifier Type: -

Identifier Source: org_study_id