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IRCT20240928063187N3 IRCT 2025-11-22 Yazd University of Medical Sciences 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 2025-12-01 anticipated 92 Complete https://irct.ir/trial/87221 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be distributed into two groups using an online randomization program. In this study, block randomization is used to allocate eligible individuals in a 1:1 ratio to treatment groups (A, B). The block size is 4, and a total of 23 blocks are considered. Each block contains an equal number of interventions. PASS 2021 software is used to generate random sequences in blocks. The sealed envelope method is used to conceal the randomization sequence. An independent biostatistician in this study will generate the randomization sequence, and then the generated random codes will be placed in the envelope and sealed, and the researchers of this study will be unaware of the treatment type. Eligible individuals will be referred in order and included in the study according to the randomization sequence and sealed envelopes. The treatment will be prepared as treatment A or B by the pharmacist according to the randomization sequence. 3 mucusitis. 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 Dental Clinic. For two weeks. Intervention 2: Control group: Benzydamine mouthwash (0.15%) available on the market from Elixir Pharmaceutical Company (Benzylazine), measuring cups (5 to 15 ml), for two weeks, every 8 hours (3 times a day). Yes - There is a plan to make this available What will be shared: Comparison of the effects of mouthwash and mucoadhesive gel containing benzydamine hydrochloride in the management of radiotherapy-induced oral mucositis When: starting 6 months after publication To whom: Everyone has access. Conditions: There are no special conditions. Where to obtain: Via email address How to obtain: Request via email address only. Comments:
public Fatemeh Owlia
Deha Fajr Boulevard, Imam Reza Street, Faculty of Dentistry, Shahid Sadoughi University of Medical Sciences, Yazd
Yazd Iran (Islamic Republic of) 3867765178 +98 35 3620 4760 f.owlia@ssu.ac.ir Yazd University of Medical Sciences scientific Fatemeh Owlia
Deha Fajr Boulevard, Imam Reza Street, Faculty of Dentistry, Shahid Sadoughi University of Medical Sciences, Yazd
Yazd Iran (Islamic Republic of) 3867765178 +98 35 3620 4760 f.owlia@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) 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. 18 years no limit Both 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. Prevention Prevention 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 Dental Clinic. For two weeks Control group: Benzydamine mouthwash (0.15%) available on the market from Elixir Pharmaceutical Company (Benzylazine), measuring cups (5 to 15 ml), for two weeks, every 8 hours (3 times a day) 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. تعیین و مقایسه شدت موکوز دهانی گروه ناشی از رادیوتراپی در بیماران سرطانی قبل و بعد از مداخله در دهانشویه و ژل مخاط چسب حاوی بنزیدآمین. 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. Yazd University of Medical Sciences Approved 2025-10-28 Research Ethics Committee, Faculty of Dentistry, Shahid Sadoughi University of Medical Sciences, Yaz Deha Fajr Boulevard, Imam Reza Street, Faculty of Dentistry, Shahid Sadoughi University of Medical Sciences, Yazd1 Yazd Yazd Iran (Islamic Republic of)