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IRCT20210830052335N1 IRCT 2021-09-09 Tabriz University of Medical Sciences The effect of 1% pilocarpine mouthwash on salivation in patients undergoing head and neck radiotherapy: a double-blind randomized clinical trial The effect of 1% pilocarpine mouthwash on salivation in patients undergoing head and neck radiotherapy: a double-blind randomized clinical trial 2021-09-23 anticipated 62 Complete https://irct.ir/trial/58396 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: 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, Blinding description: 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). 3 Xerostomia. Intervention 1: Intervention group: In the case group, in addition to 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. Intervention 2: Control group: The control group will be trained in salivary gland massage therapy and adequate hydration, and they will be given a placebo mouthwash (normal saline), which will gargle 30 drops four times a day for 2 minutes each time. Which will be used for 2 weeks after starting radiotherapy. Yes - There is a plan to make this available What will be shared: In this study, data on salivation in the two groups before and after the intervention will be published. When: Access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Dentists Conditions: If positive results are obtained, researchers can prepare this mouthwash according to the instructions and use it to prevent dry mouth in patients. Where to obtain: Paria.motahari@yahoo.com 09144197584 Paria Motahari How to obtain: The applicant sends his request via email or phone number and information and data are sent to his email. Comments:
public Paria Motahari
No. 147, 4th Floor, Mikhak One Alley, Mandana Alley, Golbad St., Abersan
Tabriz Iran (Islamic Republic of) 5165655635 +98 41 3334 7422 paria.motahari@yahoo.com Tabriz University of Medical Sciences scientific Paria Motahari
No. 147, 4th Floor, Mikhak One Alley, Mandana Alley, Golbad St., Abersan
Tabriz Iran (Islamic Republic of) 5165655635 +98 41 3334 7422 paria.motahari@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Head and neck cancers. Topical laryngeal cancer, hypopharyngeal cancer and nasopharyngeal cancer Under conventional radiation therapy with doses greater than 50 g Satisfaction to participate in the study 18 years 60 years Both Changes in the patient's treatment protocol or process of receiving radiation therapy Lack of patient cooperation in the study process Taking any medication that reduces salivation, physical systemic diseases such as Sjogren's syndrome, diabetes, Behcet's disease, hypertension and hyperthyroidism Prevention Placebo Intervention group: In the case group, in addition to 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. Control group: The control group will be trained in salivary gland massage therapy and adequate hydration, and they will be given a placebo mouthwash (normal saline), which will gargle 30 drops four times a day for 2 minutes each time. Which will be used for 2 weeks after starting radiotherapy. Salivation rate. Timepoint: Two weeks before the first (basic) radiotherapy session, the first day of radiation therapy and two and four weeks after radiation therapy. Method of measurement: For this purpose, the spitting method will be used in which patients refrain from drinking or eating anything for 90 minutes before sampling. Then, for 5 minutes, people will be asked to empty their saliva into a calibrated test tube once or twice a minute. The amount of saliva (ml in 5 minutes) will be calculated and recorded. Tabriz University of Medical Sciences Approved 2021-08-23 Research Ethics Committee of Tabriz University of Medical Sciences Golgasht St. / Tabriz University of Medical Sciences, Central Building No. 2 / Third Floor, Vice Chancellor for Research and Technology Tabriz East Azarbaijan Iran (Islamic Republic of)