Toluidine Blue O (0.1 mg/mL)630-nm LED Light DevicePhotodynamic Therapy (PDT)Sham Photodynamic Therapy
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.
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.
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.
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.
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
1. Patients aged between 18 and 65 years
2. Presence of asymptomatic apical periodontitis with necrotic pulp in single-rooted maxillary or mandibular incisors, canines, or premolars
3. Periapical Index (PAI) score ≥ 2
4. Patients classified as ASA I (American Society of Anesthesiologists Physical Status Classification)
5. Preoperative pain score \< 50 on the Visual Analog Scale (VAS)
Exclusion Criteria:
1. Multi-rooted teeth
2. Patients classified as ASA II or higher
3. Pregnant women or those with suspected pregnancy
4. Root canal curvature greater than 25° according to the Schilder method
5. Patients diagnosed with generalized periodontitis
6. Periodontal pocket depth \> 3 mm in the related tooth
7. Use of analgesic medication within the past 72 hours
8. Use of antibiotic therapy within the past month
9. Presence of swelling and positive response to palpation/percussion tests
Primary outcome measure(s)
Reduction in intracanal bacterial load measured by quantitative PCR (qPCR) — Baseline (Day 1) to Immediately After Intervention (Day 1) Intracanal bacterial load will be quantified using real-time quantitative polymerase chain reaction (qPCR). Samples will be collected at four predefined sampling points (S0-S3) using sterile #30 paper points inserted into the canal for 30 seconds.
S0 (Baseline): After isolation and disinfection, before instrumentation
S1: After access cavity preparation and working length determination
S2: After root canal instrumentation
S3 (Post-Intervention): After final irrigation protocol and photodynamic therapy (or sham procedure)
Changes in bacterial DNA concentration (copy number/µL) from S0 to S3 will be compared between groups.
Trial sites (1)
Facility
City
Region
Status
Atatürk University, Faculty of Dentistry, Department of Endodontics
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.