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Study aim
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Evaluating the effect of benzydamine hydrochloride mouthwash on the rate of nausea reflex in comparison with the use of lidocaine spray in students of the School of Dentistry, Islamic Azad University in 2019
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Design
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Clinical trial with case and control group, with parallel groups, double-blind, randomized, phase 2 on 48 patients. This is a single-blind randomized controlled trial for patients. Subjects recruited were randomly assigned into two groups.
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Settings and conduct
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Among the eligible samples, 30 randomly entered the study. Before each test, no information is given about the material and the method of operation. Tests will be conducted by a trained intern under the supervision of an oral disease specialist, who must be blind to medications. Individuals who show a GTPI rating above 2 after stimulating the Landmark markings shown in Table 1 will be included in the study and then randomly assigned to the case group (benzydamine) or to the control group (lidocaine spray). In the benzydamine group, 15ml of benzydamine hydrochloride mouthwash produced by Behvazan Daroo Company, are gargled for 1 minute, then removed and re-tested after 10 minutes. 4 puffs of 50% lidocaine spray, produced by Iran Daroo Company, are used and after 5 minutes, this test will be performed again. All tests are performed on the students of the Faculty of Dentistry of the Islamic Azad University of Tehran.
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Participants/Inclusion and exclusion criteria
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Entry requirements: People whose nausea is higher than 2 using the GTPI standard, Had breakfast two hours before the test
Conditions for non-entry: Presence of any systemic diseases, drug allergy (Benzydamine or lidocaine), Pregnant and lactating women
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Intervention groups
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Case group (15ml of benzydamine hydrochloride ) and Control group (lidocaine spray 5%)
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Main outcome variables
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Application of benzydamine hydrochloride mouthwash reduces nausea reflexes