MeboNCT06184282
Topical Mebo Versus Lidocane in Healing Time of Traumatic Oral Ulcer
A study testing MEBO and Lidocaine in people with Mebo and Lidocaine, run by October 6 University at 1 site in Egypt.
Trial summary
This study aims to assess topical MEBO application on pain relief and wound healing. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- What is being tested?
- MEBO and Lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age from 20 to 50 years.
- Both sexes.
- Systemically healthy patients.
- Patients with good oral hygiene.
Who cannot join
- Patients with any uncontrolled local or systemic disease.
- Smokers.
- Pregnancy and lactation.
- Patients allergic to the used agents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Topical Mebo Versus Lidocane in Healing Time of Traumatic Oral Ulcer: Randomized Controlled Trial
This study aims to assess topical MEBO application on pain relief and wound healing.
Read the 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.
- Conditions
- Mebo, Lidocaine, Healing, Traumatic Oral Ulceration
- Being tested
- MEBO, Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEBODrug
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.
LidocaineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| MEBO group | Experimental | 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. Receives: Drug: MEBO |
| Control Group | Active comparator | 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. Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 days after surgery
Secondary outcomes (3)
Wound Size
Wound size was measured using (UNC-15) periodontal probe. Wound size was measured at baseline and on days 2, 5, and 10.
Measured: 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
Measured: 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
Measured: 10 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start1 Jul 2023
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeboStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Ahmed Mohamed Alaraby, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184282
- Sponsor's protocol ID
- RECO6U/15-2023
- Status last verified
- Dec 2023
- First submitted
- 14 Dec 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Topical Mebo Versus Lidocane in Healing Time of Traumatic Oral Ulcer: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06184282
- Acronym / sponsor ID
- RECO6U/15-2023
- Conditions
- Mebo, Lidocaine, Healing, Traumatic Oral Ulceration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 28 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MEBO group | Experimental | Drug: MEBOMEBO (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 comparator | Drug: LidocaineLidocaine 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age from 20 to 50 years.
- Both sexes.
- Systemically healthy patients.
- Patients with good oral hygiene.
Key exclusion criteria (4 listed)
- Patients with any uncontrolled local or systemic disease.
- Smokers.
- Pregnancy and lactation.
- Patients allergic to the used agents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEBOMEBO (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 group |
| LidocaineLidocaine 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 | Control Group |
Primary outcome
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.
3 secondary outcomes
Wound Size
Time frame: 10 days after surgery
The degree of re-epithelization
Time frame: 10 days after surgery
The degree of keratinization
Time frame: 10 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEBO and Lidocaine in people with Mebo and Lidocaine, run by October 6 University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degree of pain (time frame: 10 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.