Stomatitis, Aphthous
Conditions
Keywords
Rehabilitation, Hypericum perforatum, Pain, Hyaluronic Acid, Corticosteroid
Brief summary
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.
Detailed description
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.
Interventions
DRUGKenacort A Orabase® pomad , Bristol-Myers Squibb İlaçları Inc. İstanbul , Türkiye
Apply to the injured area 4 times a day
COMBINATION_PRODUCTHyaluronic acid, Aftamed ® Oral jel , AktiFarma . İstanbul, Türkiye
Apply to the injured area 4 times a day
COMBINATION_PRODUCTHypericum perforatum (St. John's wort oil, Zade Vital; Health&Fitness, Developed With Ege Üniversiesi Argefar)
Apply to the injured area 4 times a day
Sponsors
Batman University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
patients were divided into three groups
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. 18 years and over 2. Having a history of RAS for at least 2 years 3. Having one in an easily accessible area in the mouth 4. RAS has not exceeded a period of 48 hours
Exclusion criteria
1. Having any allergic history to these substances to be applied 2. During pregnancy and lactation 3. Use of steroids, vitamins, antibiotics, antihistamines, oral retinoids or immune system regulating agents for ulcer treatment within 3 months 4. The patient has a history of systemic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain level | 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
| Measure | Time frame | Description |
|---|---|---|
| Size of ulcer | 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) |
| Ulcer healing duration | Up to 7 days | Time required for complete ulcer healing, defined as complete epithelialization without visible ulceration. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORRojdan F GÜNEŞ UYSAL, PhD
Batman University
STUDY_DIRECTORGiray G TEKİN, PhD
Batman University
Outcome results
None listed