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mouth wash efficacy for paediatric malignancies

Evaluation of the Efficacy of a Muco-Adherent Mouthwash for the Relief of Oral Mucositis in Pediatric Malignancies"

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250205064661N1
Enrollment
60
Registered
2025-08-08
Start date
2022-01-22
Completion date
Unknown
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral mucositis. Oral mucositis (ulcerative) due to antineoplastic therapy

Interventions

Intervention 1: an oral mucoadhesive gel is used to manage mucositis and stomatitis. A 5 mL dose is mixed with 5 mL of water to make a 10 mL mouthwash solution. Patients rinse the entire mouth for at

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 18 Years

Inclusion criteria

Inclusion criteria: Patients aged 6 to 18 years diagnosed with various cancers and hospitalized at Amir Hospital,Had Grade 2 or higher mucositis in previous chemotherapy that Fully recovered before the start of the study Maintain oral hygiene

Exclusion criteria

Exclusion criteria: Allergy to any components of the drugs Systemic liver and kidney disease and diabetes involvement of mucosa and skin by another disease, or viral and fungal oral infection Failure to complete the consent form Grade 4 mucositis autoimmune or rheumatologic diseases

Design outcomes

Primary

MeasureTime frame
Reduction in the incidence and severity of oral mucositis. Timepoint: Evaluation of mucositis at the beginning of the study before the start of the study and on days 5, 10, and 14. Method of measurement: All patients initially complete the WHO-validated oral mucositis questionnaire, and their scores are recorded. Only patients with a score of zero are enrolled in the study. Patients are regularly evaluated by a specialist assessor, and the CHIMES questionnaire (Chemotherapy-Induced Mucositis Evaluation Scale) is also completed to monitor disease-related complications.

Secondary

MeasureTime frame
Acceptance of patients in terms of taste and appearance characteristics of the muco-adherent mouthwash / Reduction in the duration of oral mucositis / improvment in patients quality of life. Timepoint: Evaluation of mucositis at the beginning of the study before the start of the study and on days 5, 10, and 14. Method of measurement: All patients initially complete the WHO-validated oral mucositis questionnaire, and their scores are recorded. Only patients with a score of zero are enrolled in the study. Patients are regularly evaluated by a specialist assessor, and the CHIMES questionnaire (Chemotherapy-Induced Mucositis Evaluation Scale) is also completed to monitor disease-related complications.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactReihaneh Sedghi

Shiraz University of Medical Sciences

reihaneh.sedghi@gmail.com+98 71 3632 3532

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026