Skip to main content
OpenTrials
Completed

NCT Number: NCT07135609

Apitoxin Versus Soft Laser for Management of Aphthous Ulceration.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Apitoxin Animal Diseases Aphthous Ulceration Bee Venom Therapy Foot-and-Mouth Disease Infections Management Picornaviridae Infections RNA Virus Infections Virus Diseases

Age range

15 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low-level laser therapy (LLLT)

Device

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

Apitoxin

Drug

Patients managed with 0.3% Apitoxin Gel.

Primary outcomes

  1. Ulcer Surface Area

    Time frame: 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 outcomes

  1. Pain Sensation

    Time frame: 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).

  2. Effectiveness Index (EI)

    Time frame: 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%

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Apitoxin Versus Soft Laser for Management of Aphthous Ulceration

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 22, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.