Treatment of Aphtous Ulcers With Photodynamic Therapy

Oral Ulcer Clinical Trial

Official title:

Treatment of Aphtous Ulcers With Photodynamic Therapy: A Randomised Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06379438
• Other study ID #: 06/16022018
• Status: Completed
• Phase: N/A
• Start date: March 5, 2018
• Est. completion date: March 8, 2019

Study information

• Verified date: April 2024
• Source: Yuzuncu Yil University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 8, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Oral Ulcer
• Ulcer

Intervention

Combination Product:
• Photodynamic therapy (indocyanine green+laser)
Photodynamic therapy with indocyanine green

Locations

Country	Name	City	State
Turkey	Yuzuncu Yil University	Van	Merkez

Sponsors (1)

Lead Sponsor	Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ulcer wound healing with diameter measurement	Lesion diameters were measured with a elastic ruler and the healing rate of the lesion was monitored.	One week (preoperatively and on postoperative days 3, 5 and 7 )
Primary	Level of recovery	A 3-point scale was used. Grade 1 represents "complete recovery", Grade 2 represents "moderate recovery", Grade 3 represents "little recovery".	Postoperatively 7 th day
Secondary	Pain evaluation with Visual Analogue Scale	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.	One week