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Completed

NCT Number: NCT06184282

Topical Mebo Versus Lidocane in Healing Time of Traumatic Oral Ulcer

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

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Key information

Conditions

Mebo Healing Lidocaine Traumatic Oral Ulceration

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

October 6 University

Giza, 12511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Mebo

Drug

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.

Lidocaine

Drug

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.

Primary outcomes

  1. The degree of pain

    Time frame: 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.

Secondary outcomes

  1. Wound Size

    Time frame: 10 days after surgery

    Wound size was measured using (UNC-15) periodontal probe. Wound size was measured at baseline and on days 2, 5, and 10.

  2. The degree of re-epithelization

    Time frame: 10 days after surgery

    Cytological analysis was performed using the superficial epithelial cell index indices at 2, 5 and 10 days.

    Superficial cell index = Cells with or without pyknotic nuclei / Total no. of examined cells x100

  3. The degree of keratinization

    Time frame: 10 days after surgery

    Cytological analysis was performed using keratinization indices at 2, 5 and 10 days.

    Keratinization index = Cells without nuclei / Total no. of examined cells x100

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 28, 2023
Registry last updated
Jan 3, 2024

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.

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