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

April 16, 2025 updated by: Saglik Bilimleri Universitesi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Etlik
      • Ankara, Etlik, Turkey, 06010
        • Gulhane Faculty of Dentistry, University of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. Radiographic Assessment of Lesion Healing at 6 months
Time Frame: Postoperative an avarage of 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
Time Frame: Post-Treatment at day 1, day 3, and day 7
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiome analysis
Time Frame: Posttreatment an average on 3 months
To assess the impact of aPDT on the root canal microbiota, microbiome analysis will be performed using next-generation sequencing (NGS) of the 16S rRNA gene from samples collected before and after the intervention.
Posttreatment an average on 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi

Collaborators

Health Institutes of Turkey

Investigators

  • Principal Investigator: Hulde Korucu, DDS, University of Health Sciences Gülhane Faculty of Dentistry Department of Endodontics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2024

Primary Completion (Actual)

April 7, 2025

Study Completion (Actual)

April 7, 2025

Study Registration Dates

First Submitted

April 8, 2025

First Submitted That Met QC Criteria

April 16, 2025

First Posted (Actual)

April 17, 2025

Study Record Updates

Last Update Posted (Actual)

April 17, 2025

Last Update Submitted That Met QC Criteria

April 16, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HKORUCU2
  • 37379 (Other Grant/Funding Number: Health Institutes of Turkey)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The impact of gender differences on pain assessment in the study was also evaluated. Additionally, the effect of age on lesion healing was analyzed. Since the study examines the effects of demographic data on lesion healing and post-treatment pain, demographic data will be shared.

IPD Sharing Time Frame

The IPD and supporting information will be available for 2 years following the treatment outcomes.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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