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Apitoxin Versus Soft Laser for Management of Aphthous Ulceration.

T

Tanta University

Status

Completed

Conditions

Aphthous Ulceration
Bee Venom Therapy
Apitoxin
Management

Treatments

Device: Low-level laser therapy (LLLT)
Drug: Apitoxin

Study type

Interventional

Funder types

Other

Identifiers

NCT07135609
TUCDREC/300424/ Rsabra.

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

15 to 40 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Group Ӏ
Active Comparator group
Description:
Patients managed by Low-level laser therapy (LLLT).
Treatment:
Device: Low-level laser therapy (LLLT)
Group II
Experimental group
Description:
Patients managed with 0.3% Apitoxin Gel.
Treatment:
Drug: Apitoxin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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