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Toluidine Blue-Based Photodynamic Therapy for Antibacterial Activity and Postoperative Pain

NCT07266233 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-05

No results posted yet for this study

Summary

This clinical study aims to evaluate the antimicrobial effectiveness and postoperative pain outcomes of photodynamic therapy using Toluidine Blue O as an adjunct to conventional root canal treatment in patients diagnosed with symptomatic irreversible pulpitis. Photodynamic therapy is a non-invasive light-activated disinfection method, and this study will compare its performance with standard endodontic treatment protocols. The results are expected to provide clinical evidence regarding its potential benefits in reducing intracanal bacterial load and improving postoperative patient comfort.

Conditions

  • Root Canal Infection

Interventions

DRUG

Toluidine Blue O (0.1 mg/mL)

A 0.1 mg/mL toluidine blue O solution used as the photosensitizer for photodynamic therapy. The solution is placed into the root canal prior to 630-nm LED irradiation for activation.

DEVICE

630-nm LED Light Device

A light-emitting diode device delivering 630-nm wavelength used to activate toluidine blue O during photodynamic therapy. The device is positioned near the tooth for 60 seconds.

PROCEDURE

Photodynamic Therapy (PDT)

Application of 0.1 mg/mL toluidine blue O into the root canal, followed by activation with a 630-nm LED light source for 60 seconds as part of the experimental disinfection protocol.

PROCEDURE

Sham Photodynamic Therapy

Placebo photodynamic procedure in which the LED device is positioned similarly but activated without delivering light energy; no toluidine blue O is applied.

Sponsors & Collaborators

  • Ataturk University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2025-11-07
Completion
2026-03-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07266233 on ClinicalTrials.gov