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

NCT06839313 | Completed

• 1 other identifier: BatmanU-DF-RFGU-01
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Stomatitis, Aphthous

Keywords

Rehabilitation; Hypericum perforatum; Pain; Hyaluronic Acid; Corticosteroid

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• Size of ulcer

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

• Ulcer healing duration

  Up to 7 days

Study Arms (3)

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.

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

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.

Combination Product: Hyaluronic acid, Aftamed ® Oral jel , AktiFarma . İstanbul, Türkiye

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.

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

Interventions

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

Apply to the injured area 4 times a day

Also known as: Aftamed ®

grup 2 Hyaluronic acid

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

Apply to the injured area 4 times a day

Also known as: Kenacort A Orabase®

group 1 Triamsinolon asetonid

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

Also known as: Zade Vital; Health&Fitness

grup 3 St. John's wort oil

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Batman University: lead

Study Sites (1)

Batman University

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

Location

MeSH Terms

Conditions

Stomatitis, Aphthous; Pain

Interventions

Hyaluronic Acid; Hypericum extract LI 160

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Rojdan F GÜNEŞ UYSAL, PhD

  Batman University

  PRINCIPAL INVESTIGATOR

• Giray G TEKİN, PhD

  Batman University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: patients were divided into three groups

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 21, 2025
• Study Start: February 1, 2025
• Primary Completion: August 15, 2025
• Study Completion: August 15, 2025
• Last Updated: July 8, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)