Oral Mucositis (Ulcerative) Due to Radiation
Conditions
Keywords
Moist exposed burn ointment, Oral Mucositis Assessment Scale
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.
Interventions
MEBO® 0.25% Ointment (Gulf Pharmaceutical Industries) to be applied four times a day for two weeks
Tantum verde (EIPICO®) mouthwash. Patients were asked to swish it for at least five minutes, four times daily for two weeks.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Outcome results
None listed