Apitoxin Versus Soft Laser for Management of Aphthous Ulceration.

NCT ID: NCT07135609

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2025-02-02

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.

Conditions

Apitoxin; Bee Venom Therapy; Management; Aphthous Ulceration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group Ӏ

Patients managed by Low-level laser therapy (LLLT).

Group Type: ACTIVE_COMPARATOR

Low-level laser therapy (LLLT)

Intervention Type: DEVICE

Patients managed by Low-level laser therapy (LLLT).

Group II

Patients managed with 0.3% Apitoxin Gel.

Group Type: EXPERIMENTAL

Apitoxin

Intervention Type: DRUG

Patients managed with 0.3% Apitoxin Gel.

Interventions

Low-level laser therapy (LLLT)

Patients managed by Low-level laser therapy (LLLT).

Intervention Type: DEVICE

Apitoxin

Patients managed with 0.3% Apitoxin Gel.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Omar Elboraey Elbal

Assistant Professor of Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology Department, Faculty of Dentistry, Tanta, University, Tanta, Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, El-Gharbia, Egypt

Countries

Egypt

Other Identifiers

TUCDREC/300424/ Rsabra.

Identifier Type: -

Identifier Source: org_study_id