Topical Mebo Versus Lidocane in Healing Time of Traumatic Oral Ulcer

Lidocaine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06184282
• Other study ID #: RECO6U/15-2023
• Status: Completed
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: August 1, 2023

Study information

• Verified date: December 2023
• Source: October 6 University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healing
• Lidocaine
• Oral Ulcer

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Egypt	October 6 University	Giza

Sponsors (1)

Lead Sponsor	Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The degree of pain	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.	10 days after surgery
Secondary	Wound Size	Wound size was measured using (UNC-15) periodontal probe. Wound size was measured at baseline and on days 2, 5, and 10.	10 days after surgery
Secondary	The degree of re-epithelization	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	10 days after surgery
Secondary	The degree of keratinization	Cytological analysis was performed using keratinization indices at 2, 5 and 10 days.; Keratinization index = Cells without nuclei / Total no. of examined cells x100	10 days after surgery