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临床试验/NCT07135609
NCT07135609已完成不适用

Apitoxin Versus Soft Laser for Management of Aphthous Ulceration

Tanta University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年4月30日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Ulcer Surface Area

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
15 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Group Ӏ

Active Comparator

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

干预措施: Low-level laser therapy (LLLT) (Device)

Group II

Experimental

Patients managed with 0.3% Apitoxin Gel.

干预措施: Apitoxin (Drug)

结局指标

主要结局

Ulcer Surface Area

时间窗: 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).

次要结局

  • Pain Sensation(5 days post-treatment)
  • Effectiveness Index (EI)(5 days post-treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Omar Elboraey Elbal

Assistant Professor of Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology Department, Faculty of Dentistry, Tanta, University, Tanta, Egypt

Tanta University

研究点 (1)

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