Topical Mebo Versus Lidocane in Healing Time of Traumatic Oral Ulcer
Assessment of Topical Mebo Versus Lidocane in Healing Time of Traumatic Oral Ulcer: Randomized Controlled Trial
1 other identifier
interventional
28
1 country
1
Brief Summary
This study aims to assess topical MEBO application on pain relief and wound healing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedFirst Submitted
Initial submission to the registry
December 14, 2023
CompletedFirst Posted
Study publicly available on registry
December 28, 2023
CompletedJanuary 3, 2024
December 1, 2023
1 month
December 14, 2023
December 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Wound Size
10 days after surgery
The degree of re-epithelization
10 days after surgery
The degree of keratinization
10 days after surgery
Study Arms (2)
MEBO group
EXPERIMENTALMEBO (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
ACTIVE COMPARATORLidocaine 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.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- Age from 20 to 50 years.
- Both sexes.
- Systemically healthy patients.
- Patients with good oral hygiene.
You may not qualify if:
- Patients with any uncontrolled local or systemic disease.
- Smokers.
- Pregnancy and lactation.
- Patients allergic to the used agents.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
October 6 University
Giza, 12511, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Oral Medicine, Diagnosis and Periodontology, Faculty of Dentistry, October 6 University, 6 October city, Egypt
Study Record Dates
First Submitted
December 14, 2023
First Posted
December 28, 2023
Study Start
July 1, 2023
Primary Completion
August 1, 2023
Study Completion
August 1, 2023
Last Updated
January 3, 2024
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- After the end of study for one year.
- Access Criteria
- The data will be available upon a reasonable request from the corresponding author.
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.