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临床试验/NCT06184282
NCT06184282已完成不适用

Assessment of Topical Mebo Versus Lidocane in Healing Time of Traumatic Oral Ulcer: Randomized Controlled Trial

October 6 University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2023年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
1
主要终点
The degree of pain

研究概览

简要总结

This study aims to assess topical MEBO application on pain relief and wound healing.

详细描述

One of the conditions that affect the mouth frequently is a traumatic ulcer. Between 3 and 24 % of the population are affected, which is a significant prevalence. It is symptomatic to treat traumatized ulcers. Oral wound healing is a dynamic process and complicated phenomenon involving secondary concerns, a succession of overlapping stages of rebuilding cell and tissue structure.

Inflammation, granulation tissue creation, matrix formation, re-epithelialization, and tissue remodeling are some of the cellular and physiological activities that occur during wound healing.

Oral wound healing is a dynamic process and complex phenomenon involving secondary issues, series overlapping stages of restoring tissue and cellular structures.

Since 1995, the Moist Exposed Burn Ointment (MEBO), a Chinese burn ointment, has had a recognized US patent. Beta-sitosterol, Phellodendron amurense, Scutellaria baicalensis, Coptis chinensis, Pheretima aspergillum, Beeswax, and sesame oil are all natural ingredients found in MEBO, a pure herbal extract.

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
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age from 20 to 50 years.
  • Both sexes.
  • Systemically healthy patients.
  • Patients with good oral hygiene.

排除标准

  • Patients with any uncontrolled local or systemic disease.
  • Pregnancy and lactation.
  • Patients allergic to the used agents.

研究组 & 干预措施

MEBO group

Experimental

MEBO (Julphar®, Ras Al Khaimah, United Arab Emirates) was applied using sterile plastic brush daily and the patients were recalled at 2, 5 and 10 days for evaluating the healing of the ulcer.

干预措施: MEBO (Drug)

Control Group

Active Comparator

Lidocaine gel was applied using sterile plastic brush daily and the patients were recalled at 2, 5 and 10 days for evaluating the healing of the ulcer.

干预措施: Lidocaine (Drug)

结局指标

主要结局

The degree of pain

时间窗: 10 days after surgery

Pain score was reported by the patient directly through Visual Analogue Scale (VAS) score (between 0 and 10; 0: no pain, 1:minimal pain, 5: moderate pain, and 10: severe pain) VAS was recorded daily for 1 week.

次要结局

  • Wound Size(10 days after surgery)
  • The degree of keratinization(10 days after surgery)
  • The degree of re-epithelization(10 days after surgery)

研究者

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

Amany Ahmed Mohamed Alaraby

Lecturer of Oral Medicine, Diagnosis and Periodontology, Faculty of Dentistry, October 6 University, 6 October city, Egypt

October 6 University

研究点 (1)

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