Apitoxin Versus Soft Laser for Management of Aphthous Ulceration.

Tanta University60 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Apitoxin Bee Venom Therapy Management Aphthous Ulceration

Interventions

Low-level laser therapy (LLLT)DEVICE

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

ApitoxinDRUG

Patients managed with 0.3% Apitoxin Gel.

Eligibility

Sex: ALLMin age: 15 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tanta University

Tanta, El-Gharbia, Egypt

Outcomes

Primary Outcomes

Ulcer Surface Area

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).

Time frame: 5 days post-treatment

Secondary Outcomes

Pain Sensation

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).

Time frame: 5 days post-treatment

Effectiveness Index (EI)

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%

Time frame: 5 days post-treatment

Data from ClinicalTrials.gov

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