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

Not Applicable

Completed

• Conditions: Oral Mucositis (Ulcerative) Due to Radiation
• Interventions: Drug: MEBO Wound Ointment (MEBO); Drug: Tantum Verde® mouthwash

• Registration Number: NCT07186114
• Lead Sponsor: Cairo University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-01
• Primary Completion: 2024-12-14
• Study Completion: 2024-12-14
• Status Verified: 2025-09
• Study First Submitted: 2025-09-05
• Study First Submitted QC: 2025-09-12
• Last Update Submitted: 2025-09-12
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MEBO	MEBO Wound Ointment (MEBO)	-
Tantum Verde	Tantum Verde® mouthwash	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Faculty of Dentistry - Cairo University; 🇪🇬 Cairo, Egypt

Cairo University; 🇪🇬 Cairo, Egypt