Apitoxin Versus Soft Laser for Management of Aphthous Ulceration.

Not Applicable

Completed

• Conditions: Apitoxin; Bee Venom Therapy; Management; Aphthous Ulceration
• Interventions: Device: Low-level laser therapy (LLLT); Drug: Apitoxin

• Registration Number: NCT07135609
• Lead Sponsor: Tanta University

Brief Summary

The current study evaluated the clinical effect and outcome of locally applied bee venom versus low-level laser therapy (LLLT) for the treatment of recurrent aphthous ulceration.

Detailed Description

Recurrent aphthous stomatitis (RAS) is a Painful, idiopathic, and recurrent inflammatory ulceration of the oral cavity.

Despite their widespread use, prolonged or frequent application may result in adverse effects such as oral candida. In recent years, low-level laser therapy (LLLT) has gained attention as an alternative treatment for RAS.

Apitoxin has been used traditionally to treat a variety of conditions, such as arthritis, rheumatism, back pain, cancer, and skin diseases.

Study Timeline

• Study Start: 2024-04-30
• Primary Completion: 2025-02-02
• Study Completion: 2025-02-02
• Status Verified: 2025-08
• Study First Submitted: 2025-08-14
• Study First Submitted QC: 2025-08-14
• Last Update Submitted: 2025-08-14
• Study First Posted: 2025-08-22
• Last Update Posted: 2025-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age from 15 to 40 years old.
• Both sexes.
• No current or history of systemic medical problem.
• Non-smoker.
• Suffering from pain due to recurrent aphthous stomatitis (RAS) ulceration on the oral mucosa with the following characteristics:
• Duration of 2 days or less.
• The diameter ≥ 4mm
• Not been subjected to any treatment modalities for at least four weeks before the beginning of the study.

Exclusion Criteria

• Presence of other oral mucosal ulcers other than RAS.
• Systemic disease that predisposed them to RAS (e.g., Behçet disease).
• Systemic medical problems.
• Pregnant, lactating, and postmenopausal patients.
• Smoker patients.
• Systemic or topical treatment for RAS less than four weeks before starting the study.
• Any earlier experiences of laser therapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Ӏ	Low-level laser therapy (LLLT)	Patients managed by Low-level laser therapy (LLLT).
Group II	Apitoxin	Patients managed with 0.3% Apitoxin Gel.

Primary Outcome Measures

Name	Time	Method
Ulcer Surface Area	5 days post-treatment	Ulcer Surface Area: The main outcome will be the objective measurement of the ulcer surface area. This was evaluated through photographs taken on Day 1 (baseline) and Day 5 (post-treatment).

Secondary Outcome Measures

Name	Time	Method
Pain Sensation	5 days post-treatment	Subjective evaluation of pain sensation using the Visual Analog Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). Pain will be assessed on Day 1 (baseline) and Day 5 (post-treatment).
Effectiveness Index (EI)	5 days post-treatment	Calculated improvement in pain sensation for each patient based on baseline and post-treatment Visual Analog Scale (VAS). Formula: (VAS baseline - VAS post-treatment) / VAS baseline × 100%

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt