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This study aimed to assess the efficacy of MEBO® in the treatment of already established oral mucositis. This is a randomized controlled clinical trial. The study included 36 patients with established oral mucositis, divided into two groups. Patients were randomly allocated to either receive topically applied MEBO® ointment or Benzydamine Hydrochloride (Tantum Verde) mouthwash three times a day for two weeks. We assessed the World Health Organization mucositis score (WHO), the Oral Mucositis Assessment Scale (OMAS), and the Patient-Reported Oral Mucositis Symptom (PROMS) score at baseline, and after one and two weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEBO | Experimental |
| |
| Tantum Verde | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEBO Wound Ointment (MEBO) | Drug | MEBO® 0.25% Ointment (Gulf Pharmaceutical Industries) to be applied four times a day for two weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| WHO oral mucositis score | The WHO oral mucositis score is an ordinal scale. The grades are as follows: Grade 0 is no mucositis, Grade 1 is soreness and/or erythema, Grade 2 involves ulcers and the ability to eat solids, Grade 3 indicates ulcers and the need for a liquid diet, and Grade 4 signifies ulcers with no possible oral alimentation | We assessed patients for the three outcomes at baseline, one week and at the end of the study period which is two weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry - Cairo University | Cairo | 11553 | Egypt | |||
| Cairo University |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 18, 2021 | Sep 12, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D014456 | Ulcer |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Tantum Verde® mouthwash | Drug | Tantum verde (EIPICO®) mouthwash. Patients were asked to swish it for at least five minutes, four times daily for two weeks. |
|
| Cairo |
| Egypt |