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IRCT20120101008585N5 IRCT 2018-02-01 Shiraz University of Medical Sciences Evaluation the effect of a synthetic mouthwash on the oral ulcers pain and size Evaluation of the effect of a synthetic mouthwash(doxepin, chitosan) on the oral ulcers pain and size in comparison with common analgesic mouthwash (Diphenhydramine, AlMgS, lidocaine gel) 2018-02-20 anticipated 20 Complete https://irct.ir/trial/28516 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: block randomization individual Unit of randomization Tools used in randomization is table of random number, Blinding description: The investigator who evaluate the level of pain and the data analyser also are blind to the type of prescribed mouthwash. 2 oral ulcer. Intervention 1: Intervention group: in main intervention group the patients will use this formulated mouthwash (chitosan, doxepin) made in Shiraz Pharmacy University as an analgesic agent. The participants will use their mouthwash three times a day until they suffer from pain. Intervention 2: Control group: In control group patients will use common combination ,Diphenhydramine HCL 12.5 mg/5ml(Alhavi) AND suspension Aluminium MgS(Tolid-daru) and lidocaine gel 2%(Sina Daru). The participants will use their mouthwash three times a day until they suffer from pain. Yes - There is a plan to make this available What will be shared: specific participant data sets are to be shared (e.g., all collected deidentified IPD, IPD collected for the primary outcome mean and statistical analysis When: starting 1year after publication To whom: The researcher who will email the responsible individual in this study and send the request Conditions: The researcher who will email the responsible individual in this study and this person should be an academic member of medical universities. Where to obtain: The data will be obtainable by email. How to obtain: The researcher who will email the responsible individual in this study and send the request. Comments:
public Fatemeh Lavaee
Shiraz Dental Faculty, Ghasrdasht street, Shiraz
Shiraz Iran (Islamic Republic of) 7195944315 +98 71 3626 3193 fatemeh.lavaee@gmail.com Shiraz University of Medical Sciences scientific Fatemeh Lavaee
Shiraz Dental Faculty, Ghasrdasht street, Shiraz
Shiraz Iran (Islamic Republic of) 7195944315 +98 71 3626 3193 fatemeh.lavaee@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) The patient who has painful new oral lesion without receiving any treatment The patients who are not pregnant The patients who are not diabetic The patients with no other inflammatory diseases The patients who sign the written consent form 12 years no limit Both The patients who have used any analgesic agents (systemic or local) since 2 days ago The patients who have used any anti-inflammatory medication such as corticosteroid since 2 weeks ago K12.39 Other oral mucositis (ulcerative) Treatment - Drugs Treatment - Drugs Intervention group: in main intervention group the patients will use this formulated mouthwash (chitosan, doxepin) made in Shiraz Pharmacy University as an analgesic agent. The participants will use their mouthwash three times a day until they suffer from pain. Control group: In control group patients will use common combination ,Diphenhydramine HCL 12.5 mg/5ml(Alhavi) AND suspension Aluminium MgS(Tolid-daru) and lidocaine gel 2%(Sina Daru). The participants will use their mouthwash three times a day until they suffer from pain. Level of pain. Timepoint: after gargling these analgesics agent for 5 minute, VAS of patients will be measured in 5, 15, 30 and 1 hour intervals. Their VAS will be measured after each gargling also in day 1,2,3. Method of measurement: visual analogue scale. The size of oral ulcer. Timepoint: The size of oral lesions will be measured after gargling in day 1,2,3 in intervention and control groups. Method of measurement: scaled tongue blade. The side effects of using mouth washes. Timepoint: day 1,2,3 and a week after using mouth wash. Method of measurement: asking the patient. Shiraz University of Medical Sciences Approved 2017-12-10 Ethics committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences, Zand street, Shiraz Shiraz Fars Iran (Islamic Republic of)