Treatment of Aphtous Ulcers With Photodynamic Therapy

Not Applicable

Completed

• Conditions: Aphthous Recurrent Ulcers; Oral Ulcer
• Interventions: Combination Product: Photodynamic therapy (indocyanine green+laser)

• Registration Number: NCT06379438
• Lead Sponsor: Yuzuncu Yıl University

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.

Study Timeline

• Study Start: 2018-03-05
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-08
• Status Verified: 2024-04
• Study First Submitted: 2024-04-18
• Study First Submitted QC: 2024-04-18
• Last Update Submitted: 2024-04-18
• Study First Posted: 2024-04-23
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Photodynamic Therapy (PDT) Group	Photodynamic therapy (indocyanine green+laser)	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.

Primary Outcome Measures

Name	Time	Method
Ulcer wound healing with diameter measurement	One week (preoperatively and on postoperative days 3, 5 and 7 )	Lesion diameters were measured with a elastic ruler and the healing rate of the lesion was monitored.
Level of recovery	Postoperatively 7 th day	A 3-point scale was used. Grade 1 represents "complete recovery", Grade 2 represents "moderate recovery", Grade 3 represents "little recovery".

Secondary Outcome Measures

Name	Time	Method
Pain evaluation with Visual Analogue Scale	One week	For lesion-related pain follow-up, patients in the PDT group were asked to score the pain they felt on VAS on preoperative, 1st, 3rd, 5th and 7th days. VAS measurements of the patients in the control group were made on days 1, 3, 5 and 7.

Trial Locations

Locations (1)

Yuzuncu Yil University; 🇹🇷 Van, Merkez, Turkey