Topical Mebo Versus Lidocane in Healing Time of Traumatic Oral Ulcer

Study Overview
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Brief Summary
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This study aims to assess topical MEBO application on pain relief and wound healing.

Detailed Description
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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.

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

Conditions
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Mebo, Lidocaine, Healing, Traumatic Oral Ulceration

Intervention / Treatment
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* Drug: MEBO
* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MEBO group<br>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. | Drug: MEBO<br>* 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.<br>|
| Active Comparator: Control Group<br>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. | Drug: Lidocaine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |