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

NCT07186114 | Completed Phase 3 DMC

• 1 other identifier: MeboOM
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Oral Mucositis (Ulcerative) Due to Radiation

Keywords

Moist exposed burn ointment; Oral Mucositis Assessment Scale

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

MEBO

EXPERIMENTAL

Drug: MEBO Wound Ointment (MEBO)

Tantum Verde

ACTIVE COMPARATOR

Drug: Tantum Verde® mouthwash

Interventions

MEBO Wound Ointment (MEBO) DRUG

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

MEBO

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.

Tantum Verde

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Faculty of Dentistry - Cairo University

Cairo, 11553, Egypt

Location

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Stomatitis; Ulcer

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Oral Medicine and Periodontology- Faculty of Dentistry

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 22, 2025
• Study Start: March 1, 2023
• Primary Completion: December 14, 2024
• Study Completion: December 14, 2024
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)