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

NCT06931678 | Completed

• 2 other identifiers: HKORUCU237379
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Post-Treatment at day 1, day 3, and day 7

Other Outcomes (1)

• Microbiome analysis

  Posttreatment an average on 3 months

Study Arms (1)

Necrotic pulped, mature teeth with apical periodontitis

EXPERIMENTAL

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.

Procedure: aPDT

Interventions

aPDT 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.

Necrotic pulped, mature teeth with apical periodontitis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead
• Health Institutes of Turkey: collaborator

Study Sites (1)

Gulhane Faculty of Dentistry, University of Health Sciences

Ankara, Etlik, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Dental Pulp Necrosis; Periapical Periodontitis

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Periapical Diseases; Jaw Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Study Officials

• Hulde Korucu, DDS

  University of Health Sciences Gülhane Faculty of Dentistry Department of Endodontics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 17, 2025
• Study Start: October 21, 2024
• Primary Completion: April 7, 2025
• Study Completion: April 7, 2025
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The IPD and supporting information will be available for 2 years following the treatment outcomes.

Locations

TU (1)