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

Cairo University (CU)

Status and phase: Completed; Phase 3

Conditions: Oral Mucositis (Ulcerative) Due to Radiation

Treatments: Drug: Tantum Verde® mouthwash; Drug: MEBO Wound Ointment (MEBO)

Study type: Interventional

Funder types: Other

Identifiers

NCT07186114

MeboOM

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

MEBO

Experimental group

Treatment:

Drug: MEBO Wound Ointment (MEBO)

Tantum Verde

Active Comparator group

Treatment:

Drug: Tantum Verde® mouthwash