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NCT Number: NCT06839313

Comparison of Hypericum Perforatum, Topical Corticosteroids, and Hyaluronic Acid for Recurrent Aphthous Stomatitis

Recurrent aphthous stomatitis (RAS) is one of the most common ulcerative diseases of the oral mucosa and is characterized by recurrent painful ulcers that adversely affect eating, speaking, and overall quality of life. Although several topical agents are available to relieve symptoms and promote healing, no definitive treatment has yet been established.

This randomized prospective study was designed to compare the clinical effectiveness of Hypericum perforatum, topical corticosteroids, and hyaluronic acid in patients with recurrent aphthous stomatitis. The primary outcome was pain reduction, while secondary outcomes included ulcer size reduction and healing duration.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Batman University

Batman, Centre/Batman, 72100, Turkey (Türkiye)

About this study

The etiology of recurrent aphthous stomatitis (RAS) remains incompletely understood. Various topical and systemic therapeutic approaches have been proposed to reduce pain, accelerate ulcer healing, and improve patients' quality of life. Topical agents remain the first-line treatment for symptomatic management of RAS.

Triamcinolone acetonide (TA), a topical corticosteroid with potent anti-inflammatory properties, is widely used in the treatment of RAS. Hyaluronic acid (HA) gel has also demonstrated favorable clinical outcomes by reducing pain and promoting ulcer healing without significant adverse effects. In addition, Hypericum perforatum (St. John's wort) possesses anti-inflammatory, antimicrobial, antioxidant, and wound-healing properties, suggesting its potential as an alternative topical treatment for RAS.

This randomized prospective study was designed to compare the clinical effectiveness of topical Hypericum perforatum, topical triamcinolone acetonide, and hyaluronic acid gel in patients with recurrent aphthous stomatitis. The primary outcome was pain reduction, whereas secondary outcomes included ulcer size reduction and healing duration.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years and over
  • Having a history of RAS for at least 2 years
  • Having one in an easily accessible area in the mouth
  • RAS has not exceeded a period of 48 hours

Exclusion criteria

  • Having any allergic history to these substances to be applied
  • During pregnancy and lactation
  • Use of steroids, vitamins, antibiotics, antihistamines, oral retinoids or immune system regulating agents for ulcer treatment within 3 months
  • The patient has a history of systemic disease

Treatment and study plan

Kenacort A Orabase® pomad , Bristol-Myers Squibb İlaçları Inc. İstanbul , Türkiye

Drug

Apply to the injured area 4 times a day

Other names: Kenacort A Orabase®

Hyaluronic acid, Aftamed ® Oral jel , AktiFarma . İstanbul, Türkiye

Combination Product

Apply to the injured area 4 times a day

Other names: Aftamed ®

Hypericum perforatum (St. John's wort oil, Zade Vital; Health&Fitness, Developed With Ege Üniversiesi Argefar)

Combination Product

Apply to the injured area 4 times a day

Other names: Zade Vital; Health&Fitness

Primary outcomes

  1. Pain level

    Time frame: Pain levels will be measured on days 0, 3, 5 and 7.

    Pain intensity will be assessed using a 10-cm visual analogue scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain.

Secondary outcomes

  1. Size of ulcer

    Time frame: Size of ulcer will be measured on days 0, 3, 5 and 7.

    The size of the ulcer will be measured with a vernier caliper(mm)

  2. Ulcer healing duration

    Time frame: Up to 7 days

    Time required for complete ulcer healing, defined as complete epithelialization without visible ulceration.

Sponsors and collaborators

Lead sponsor

Batman University

Other

Registry information

Official study title

Comparative Evaluation of Hypericum Perforatum, Topical Corticosteroids, and Hyaluronic Acid in the Treatment of Recurrent Aphthous Stomatitis: A Randomized Controlled Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2025
Registry last updated
Jul 8, 2026

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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