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NCT Number: NCT07186114

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

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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Key information

Conditions

Oral Mucositis (Ulcerative) Due to Radiation Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stomatitis Stomatognathic Diseases Ulcer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cairo University, Cairo, Egypt

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. WHO oral mucositis score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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