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Comparison of the effects of mouthwash and in situ gel containing benzydamine hydrochloride in the management of oral mucositis

Comparison of the effects of mouthwash and in situ gel containing benzydamine hydrochloride in the management of radiotherapy-induced oral mucositis

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240928063187N3
Enrollment
92
Registered
2025-11-22
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

mucusitis.

Interventions

Intervention 1: Intervention group: Mucoadhesive gel in the form of a spray, which is sprayed on the mucosa every 8 hours (3 times a day), was developed by the dental materials team of Shahid Beheshti

Sponsors

Yazd University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients over 18 years of age with head and neck cancer who require radiation therapy with a dose of at least 60 Gy. Willingness to participate in the study Have the ability to rinse and gargle They have no smoking during radiotherapy.

Exclusion criteria

Exclusion criteria: 1) Patients with any source of infection in the mouth 2) Patients using dentures 3) History of allergy to chitosan or benzydamine 4) Patients with a history of previous cancer treatment.

Design outcomes

Primary

MeasureTime frame
Determining and comparing the pain level of oral mucositis caused by radiotherapy in cancer patients before and after intervention in the mouthwash and mucoadhesive gel groups containing benzydamine. Timepoint: Follow-up will be conducted for 2 weeks and in 4 sessions (days 3, 5, 7 and 14). Method of measurement: Visual Analogue Scale.

Secondary

MeasureTime frame
????? ? ?????? ??? ????? ????? ???? ???? ?? ?????????? ?? ??????? ?????? ??? ? ??? ?? ?????? ?? ???????? ? ?? ???? ??? ???? ?????????. Timepoint: Follow-up will be conducted for 2 weeks and in 4 sessions (days 3, 5, 7 and 14). Method of measurement: WHO Mucositis Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Owlia

Yazd University of Medical Sciences

f.owlia@ssu.ac.ir+98 35 3620 4760

Outcome results

None listed

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