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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-12-14

Brief Summary

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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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Detailed Description

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Conditions

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Oral Mucositis (Ulcerative) Due to Radiation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MEBO

Group Type EXPERIMENTAL

MEBO Wound Ointment (MEBO)

Intervention Type DRUG

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

Tantum Verde

Group Type ACTIVE_COMPARATOR

Tantum Verde® mouthwash

Intervention Type DRUG

Tantum verde (EIPICO®) mouthwash. Patients were asked to swish it for at least five minutes, four times daily for two weeks.

Interventions

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MEBO Wound Ointment (MEBO)

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

Intervention Type DRUG

Tantum Verde® mouthwash

Tantum verde (EIPICO®) mouthwash. Patients were asked to swish it for at least five minutes, four times daily for two weeks.

Intervention Type DRUG

Eligibility Criteria

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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 .