Apitoxin Versus Soft Laser for Management of Aphthous Ulceration.

NCT07135609 | Completed

• 1 other identifier: TUCDREC/300424/ Rsabra.
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Apitoxin; Bee Venom Therapy; Management; Aphthous Ulceration

Outcome Measures

Primary Outcomes (1)

• 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).

  5 days post-treatment

Secondary Outcomes (2)

• Pain Sensation

  5 days post-treatment

• Effectiveness Index (EI)

  5 days post-treatment

Study Arms (2)

Group Ӏ

ACTIVE COMPARATOR

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

Device: Low-level laser therapy (LLLT)

Group II

EXPERIMENTAL

Patients managed with 0.3% Apitoxin Gel.

Drug: Apitoxin

Interventions

Low-level laser therapy (LLLT) DEVICE

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

Group Ӏ

Apitoxin DRUG

Patients managed with 0.3% Apitoxin Gel.

Group II

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Foot-and-Mouth Disease

Interventions

Low-Level Light Therapy; Bee Venoms

Condition Hierarchy (Ancestors)

Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Animal Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Arthropod Venoms; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology Department, Faculty of Dentistry, Tanta, University, Tanta, Egypt

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 22, 2025
• Study Start: April 30, 2024
• Primary Completion: February 2, 2025
• Study Completion: February 2, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)