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Treatment of Aphtous Ulcers With Photodynamic Therapy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06379438
Enrollment
30
Registered
2024-04-23
Start date
2018-03-05
Completion date
2019-03-08
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aphthous Recurrent Ulcers, Oral Ulcer

Keywords

photodynamic therapy, aphtous ulcer, indocyanine green

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.

Interventions

COMBINATION_PRODUCTPhotodynamic therapy (indocyanine green+laser)

Photodynamic therapy with indocyanine green

Sponsors

Yuzuncu Yil University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Ulcer wound healing with diameter measurementOne 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 recoveryPostoperatively 7 th dayA 3-point scale was used. Grade 1 represents complete recovery, Grade 2 represents moderate recovery, Grade 3 represents little recovery.

Secondary

MeasureTime frameDescription
Pain evaluation with Visual Analogue ScaleOne weekFor 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026