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IRCT20200108046050N1 IRCT 2021-12-01 Tabriz University of Medical Sciences Effect of pilocarpine mouthwash on symptoms and salivary flow rate The evaluation of the dose-related effect of pilocarpine mouthwash on symptoms and salivary flow rate in patients with xerostomia 2021-11-22 anticipated 60 Complete https://irct.ir/trial/60037 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Individuals will be randomly assigned to one of four study groups with the help of a random number table and will receive the intervention of the allocated group. For allocation concealment, the method of sealed opaque envelopes which are numbered sequentially will be used. In this method, each random sequence is recorded on a card. Finally, the lids of the letter envelopes will be glued and placed inside a box. At the beginning of the registration of participants, according to the order of entry of eligible participants to study, one of the envelopes will be opened in order and the assigned group of the participant will be revealed, Blinding description: The study is a double-blind randomized clinical trial in which blindness will be performed for both researchers and participants. In this way, 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 the participants) and only one of the project partners who knows the contents of the mouthwashes will distribute the mouthwashes among patients. Acquiring saliva samples and examinations will be performed by other research partner who is blind to groups (blinding of researchers). 3 xerostomia. Intervention 1: Control group: Placebo 10 ml normal saline serum, Every 8 hours, 30 drops will be mouth washed for 2 minutes. Intervention 2: Intervention group1: Pilocarpine 1% mouthwash: To prepare a mouthwash with a dilution of 1.0%, 5 ml of 2% pilocarpine eye drops Sina darou will be mixed with 9.5 ml of normal saline until a final volume of 10 ml. Intervention 3: Intervention group 2: Pilocarpine 1.5% mouthwash: To prepare a mouthwash with a dilution of 1.5%, 7.5 ml of 2% pilocarpine eye drops Sina darou will be mixed with 9.5 ml of normal saline until a final volume of 10 ml. Intervention 4: Intervention group 3: Pilocarpine 2% mouthwash: To prepare a mouthwash with a dilution of 2%, 10 ml of 2% pilocarpine eye drops Sina darou will be used. Yes - There is a plan to make this available What will be shared: The main outcomes of the study, including saliva volume and symptoms, 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 institutes, doctors and dentists Conditions: Use of the data for further research or treatment is permitted. Where to obtain: Katayoun Katebi 00984133355965 Department of oral medicine, Tabriz faculty of dentistry katebik@tbzmed.ac.ir How to obtain: The applicant sends request via email and information and data will be sent to email Comments:
public Katayoun Katebi
Oral medicine department, faculty of Dentistry, Tabriz university of medical sciences, Golgasht street
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 6955 katebik@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Katayoun Katebi
Oral medicine department, faculty of Dentistry, Tabriz university of medical sciences, Golgasht street
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 6955 katebik@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) People who have had dry mouth for 3 months or more People with age between 20 to 60 People who have informed consent to participate in the study 20 years 60 years Both People with acute asthma attack or narrow-angle glaucoma or acute iris inflammation Women who are pregnant or breastfeeding People who have heart disease People whose dry mouth is caused by radiotherapy to the head and neck R68.2 Dry mouth, unspecified Placebo Rehabilitation Rehabilitation Rehabilitation Control group: Placebo 10 ml normal saline serum, Every 8 hours, 30 drops will be mouth washed for 2 minutes Intervention group1: Pilocarpine 1% mouthwash: To prepare a mouthwash with a dilution of 1.0%, 5 ml of 2% pilocarpine eye drops Sina darou will be mixed with 9.5 ml of normal saline until a final volume of 10 ml. Intervention group 2: Pilocarpine 1.5% mouthwash: To prepare a mouthwash with a dilution of 1.5%, 7.5 ml of 2% pilocarpine eye drops Sina darou will be mixed with 9.5 ml of normal saline until a final volume of 10 ml. Intervention group 3: Pilocarpine 2% mouthwash: To prepare a mouthwash with a dilution of 2%, 10 ml of 2% pilocarpine eye drops Sina darou will be used. Salivary flow rate. Timepoint: Before intervention, after 30 minutes and 2 weeks after initiation of pilocarpine mouthwash use. Method of measurement: Measurement of the volume of saliva collected in 5 minutes in a calibrated test tube. Xerostomia symptoms. Timepoint: Before intervention, after 30 minutes and 2 weeks after initiation of pilocarpine mouthwash use. Method of measurement: Visual Analogue Scale. Tabriz University of Medical Sciences Approved 2021-10-25 Ethics committee of Tabriz University of Medical Sciences Tabriz faculty of dentistry, Golghasht street Tabriz East Azarbaijan Iran (Islamic Republic of)