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Completed

NCT Number: NCT06379438

Treatment of Aphtous Ulcers With Photodynamic Therapy

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.

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Key information

Conditions

Oral Ulcer Aphthous Recurrent Ulcers Mouth Diseases Stomatitis Stomatitis, Aphthous Stomatognathic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yuzuncu Yil University

Van, Merkez, 65080, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Photodynamic therapy (indocyanine green+laser)

Combination Product

Photodynamic therapy with indocyanine green

Primary outcomes

  1. Ulcer wound healing with diameter measurement

    Time frame: 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.

  2. Level of recovery

    Time frame: 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 outcomes

  1. Pain evaluation with Visual Analogue Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 23, 2024
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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