Topical Mebo Versus Lidocane in Healing Time of Traumatic Oral Ulcer

Not Applicable

Completed

• Conditions: Lidocaine; Healing; Traumatic Oral Ulceration; Mebo
• Interventions: Drug: MEBO; Drug: Lidocaine

• Registration Number: NCT06184282
• Lead Sponsor: October 6 University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2023-07-01
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-01
• Status Verified: 2023-12
• Study First Submitted: 2023-12-14
• Study First Submitted QC: 2023-12-14
• Study First Posted: 2023-12-28
• Last Update Submitted: 2023-12-28
• Last Update Posted: 2024-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MEBO group	MEBO	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.
Control Group	Lidocaine	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 Outcome Measures

Name	Time	Method
The degree of pain	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 Outcome Measures

Name	Time	Method
Wound Size	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.
The degree of keratinization	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
The degree of re-epithelization	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

Trial Locations

Locations (1)

October 6 University; 🇪🇬 Giza, Egypt