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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 Triamsinolon asetonid | Active Comparator | % 0,1 Triamsinolon asetonid (Kenacort- A orabase pomad) will be used on ulcer areas 4 times a day (after meals and before going to bed) for 7 days. |
|
| grup 2 Hyaluronic acid | Active Comparator | Hyaluronic acid gel (Aftamed ® Oral gel, AktiFarma, Istanbul, Turkey) will be used on ulcer areas 4 times a day (after meals and before bedtime) for 7 days. |
|
| grup 3 St. John's wort oil | Experimental | Hypericum perforatum (St. John's wort oil, Zade Vital; Health&Fitness, Developed With Ege University Argefar) will be used on ulcer areas 4 times a day (after meals and before going to bed) for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kenacort A Orabase® pomad , Bristol-Myers Squibb İlaçları Inc. İstanbul , Türkiye | Drug | Apply to the injured area 4 times a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain level | 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. | Pain levels will be measured on days 0, 3, 5 and 7. |
| Measure | Description | Time Frame |
|---|---|---|
| Size of ulcer | The size of the ulcer will be measured with a vernier caliper(mm) | Size of ulcer will be measured on days 0, 3, 5 and 7. |
| Ulcer healing duration | Time required for complete ulcer healing, defined as complete epithelialization without visible ulceration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rojdan F GÜNEŞ UYSAL, PhD | Batman University | Principal Investigator |
| Giray G TEKİN, PhD | Batman University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Batman University | Batman | Centre/Batman | 72100 | Turkey (Türkiye) |
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patients were divided into three groups
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The investigator responsible for outcome assessment was blinded to treatment allocation. Due to the nature of the interventions, neither the participants nor the investigator administering the treatments could be blinded.
| Hyaluronic acid, Aftamed ® Oral jel , AktiFarma . İstanbul, Türkiye | Combination Product | Apply to the injured area 4 times a day |
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| 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 |
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| Up to 7 days |
| ID | Term |
|---|---|
| D013281 | Stomatitis, Aphthous |
| D010146 | Pain |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| C422326 | Hypericum extract LI 160 |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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