The effect of 1% pilocarpine mouthwash on salivation in patients undergoing head and neck radiotherapy: a double-blind randomized clinical trial

Due to its many side effects, pilocarpine tablets are not routinely prescribed in Iran for patients undergoing radiotherapy. The aim of this study was to evaluate the effect of pilocarpine as a mouthwash on patients undergoing radiotherapy.

The clinical trial has a control group with randomized double-blind randomized parallel groups with phase 3 random allocation law on 62 patients.

It is a double-blind study that blindness will be performed for both therapists and treatable individuals. In this study, the target population will be all patients undergoing cervical radiotherapy referred to the radiotherapy ward of Shahid Madani Hospital in Tabriz.

In this double-blind randomized clinical trial, the study population included 62 patients with head and neck cancers (eg, locally advanced laryngeal cancer, locally advanced hypopharyngeal cancer, and oral and throat cancer). They will undergo radiotherapy in the radiotherapy center of Tabriz Civil Hospital.

Both case and control groups will include 31 patients. The control group will be trained in salivary gland massage therapy and adequate hydration, and will be given a normal saline mouthwash, gargling thirty drops four times a day for 2 minutes. In the case group, in addition to the previously mentioned massage therapy training, pilocarpine hydrochloride mouthwash will be distributed, which will gargle 30 drops for 2 minutes four times a day. The intervention will continue for 2 weeks after radiotherapy.

Unstimulated salivary flow rate will be measured in four stages : two weeks before the first (basic) radiotherapy session, the first day of radiation therapy, and two and four weeks after radiation therapy.the amount of saliva (ml in 5 minutes) will be calculated and recorded.

Samples will be divided into case and control groups using a random allocation rule. In this way, 31 balls for the case group and 31 balls for the control group will be placed inside the lottery container and then the balls will be randomly recorded without being replaced from the container and the created sequence. To avoid selection bias, random assignment to Study groups will be hidden and this sequence will remain hidden until interventions are made.

The study is a double-blind randomized clinical trial in which blinding will be performed for both therapists and treatable individuals. After making the mouthwashes, they will be transferred and labeled in containers with the same shape and packaging, and only the number of mouthwashes and placebo will be recorded on the label (blinding of treatable people) and only one of the design colleagues who has the contents of the mouthwash Will know how to allocate patients in groups, will distribute mouthwashes among patients, and examination and collection of saliva samples will be performed by another project partner who does not know the type of patient group (blinding therapists).

In this study, data on salivation in the two groups before and after the intervention will be published.

Access period starts 6 months after the results are published

Researchers working in academic and scientific institutions Dentists

If positive results are obtained, researchers can prepare this mouthwash according to the instructions and use it to prevent dry mouth in patients.

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