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Apitoxin Versus Soft Laser for Management of Aphthous Ulceration.

Apitoxin Versus Soft Laser for Management of Aphthous Ulceration

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07135609
Enrollment
60
Registered
2025-08-22
Start date
2024-04-30
Completion date
2025-02-02
Last updated
2025-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apitoxin, Bee Venom Therapy, Management, Aphthous Ulceration

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.

Interventions

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

DRUGApitoxin

Patients managed with 0.3% Apitoxin Gel.

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Ulcer Surface Area5 days post-treatmentUlcer 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

MeasureTime frameDescription
Pain Sensation5 days post-treatmentSubjective 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-treatmentCalculated 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%

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026