Treatment of Aphtous Ulcers With Photodynamic Therapy

NCT ID: NCT06379438

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-05
• Study Completion Date: 2019-03-08

Brief Summary

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.

Detailed 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.

Conditions

Oral Ulcer; Aphthous Recurrent Ulcers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Photodynamic Therapy (PDT) Group

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.

Group Type: EXPERIMENTAL

Photodynamic therapy (indocyanine green+laser)

Intervention Type: COMBINATION_PRODUCT

Photodynamic therapy with indocyanine green

Control Group

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.)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Photodynamic therapy (indocyanine green+laser)

Photodynamic therapy with indocyanine green

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yuzuncu Yıl University

OTHER

Sponsor Role: lead

Responsible Party

Cennet Neslihan Eroglu

Assoc Prof Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cennet N Eroglu, DDS,PhD

Role: PRINCIPAL_INVESTIGATOR

Yuzuncu Yıl University

Locations

Yuzuncu Yil University

Van, Merkez, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

06/16022018

Identifier Type: -

Identifier Source: org_study_id