Treatment of Aphtous Ulcers With Photodynamic Therapy

Yuzuncu Yıl University

Status: Completed

Conditions: Oral Ulcer; Aphthous Recurrent Ulcers

Treatments: Combination Product: Photodynamic therapy (indocyanine green+laser)

Study type: Interventional

Funder types: Other

Identifiers

NCT06379438

06/16022018

Details and patient eligibility

About

The search for methods that can shorten the treatment process of aphthous ulcers, the etiology of which is not fully understood, continues. The aim of this study was to determine whether photodynamic therapy (PDT) is a clinically effective alternative in the treatment of oral aphthous ulcers.

Full description

After sample size calculation, photodynamic therapy and control groups were formed with 15 patients with aphthous ulcer in each group. Laser therapy with indocyanine green was applied to the photodynamic therapy group on the day they were admitted to the clinic. No treatment was performed in the control group and only follow-up was performed. Lesion diameters, pain intensity and degree of improvement at the end of 1 week were recorded in all patients.

Enrollment: 30 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ASA-1 patients without any systemic disease,
• With a history of canker sores not exceeding 2 days,
• Not taking any antibiotics or anti-inflammatory drugs.

Exclusion criteria

• Laser therapy contraindicated,
• Pregnancy,
• Smoking habbit,
• Poor oral hygiene,
• Patients under 18 years of age

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Photodynamic Therapy (PDT) Group

Experimental group

Description:

Patients in the PDT group were treated in a single session on the day of admission to the clinic. Indocyanine green (Perio green, Elexxion AG, Radolfzell, Germany) prepared and applied according to manufacturer's instructions steps (mixing, application, soaking phase, rinsing, activation) in a concentration with 0.1mg/mL was administered via fine-needle syringe as the photosensitizer. Following the completion of topical application of the photosensitizer to the lesion surface, a (GaAlAs) diode laser device (Cheese Diode Laser, Wuhan Gigaa Optronics Technology Co. Ltd, China) in continuous mode (810 nm, 300 mW, 10,000 kHz, 1.26 cm2 spot area), with a 400 μm polymethylmethacrylate optical fiber tip, scanning from the periphery to the center of the lesion with an energy density of approximately 10 J/cm2 for 40 s and applied non-contact at a distance of 1 mm.

Treatment:

Combination Product: Photodynamic therapy (indocyanine green+laser)

Control Group

No Intervention group

Description:

The lesions of the patients in the control group were not treated but only followed up. Recommendations were made to reduce their pain (avoidance of hot, spicy and acidic foods, attention to oral hygiene, etc.)