A Prospective Study on the Therapeutic Outcomes of Mebo and Tantum Verde in Patients With Oral Mucositis

NCT07186114 — Phase 3, Completed, 36 participants, Cairo University

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Registry	NCT07186114
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	36 (Actual)
Sponsor	Cairo University (Other)
Conditions	Oral Mucositis (Ulcerative) Due to Radiation
Interventions	MEBO Wound Ointment (MEBO), Tantum Verde® mouthwash (Drug)
Dates	start 2023-03-01, primary completion 2024-12-14, completion 2024-12-14, first posted 2025-09-22, last updated 2025-09-22
Locations	2 sites in Egypt

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
MEBO	Experimental	Drug: MEBO Wound Ointment (MEBO)
Tantum Verde	Active comparator	Drug: Tantum Verde® mouthwash

MEBO Wound Ointment (MEBO) (Drug): MEBO® 0.25% Ointment (Gulf Pharmaceutical Industries) to be applied four times a day for two weeks
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.

+Outcome measures

Primary outcomes

WHO oral mucositis score [We assessed patients for the three outcomes at baseline, one week and at the end of the study period which is two weeks]: 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

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Patients who later on during radiotherapy developed oral mucositis with a severity of WHO score II or more and were over 18 years were then included in the study and allocated to one of the treatment groups .

Exclusion Criteria:

* We excluded patients who were receiving any prophylactic agents and/or corticosteroids and those who would not sign the informed consent.

+Locations (2)

Facility	City	Country	Status
Faculty of Dentistry - Cairo University	Cairo	Egypt
Cairo University	Cairo	Egypt

+Study documents

Study Protocol, Statistical Analysis Plan, and Informed Consent Form (PDF, 2021-04-18)