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IRCT201411269014N49 IRCT 2014-12-02 Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences Effect of Propolis gel versus placebo on wound treatment in patients with recurrent minor aphtous ulceration Effect of Propolis gel versus placebo on wound treatment in patients with recurrent minor aphtous ulceration: a double-blind randomized clinical trial 2014-11-26 anticipated 50 Complete https://irct.ir/trial/9488 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization: random assignment of the patients systematically one at a time to intervention and control groups. Blinding: both propolis gel versus orabase gel (placebo) will be prepared in dark and similar containers thus patients will not be aware of the type of treatment they receive. In addition, the examiner who will examine the patients is another person that will not be aware of the type of intervention. Therefore, the trial will be run as double blinded. 2 aphtous ulcers. Intervention 1: putting 1 cm in length of Propolis gel on aphtous ulcers 4 time a day for 6 days. Intervention 2: putting 1 cm in length of orabase gel (placebo) on aphtous ulcers 4 time a day for 6 days.
public Azadeh Moslemkhani
Dentistry School, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) +98 81 3838 1086 freebird_a90@yahoo.com Dentistry School scientific Dr Sharmin Abdollahzadeh
Dentistry School, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) +98 81 3838 1086 shery13562002@yahoo.com Dentistry School Iran (Islamic Republic of) Inclusion criteria: (a) age of 15 to 60 years; (b) having recurrent minor aphtous ulcers; (c) history of disease for more than one year with at least two recurrence a year; (d) having 1 to 6 ulceration if each episode; (e) less than 72 hours from the begging of the ulceration; (f) the duration of healing without medication is not more than 7 days; (g) the size of ulcers is not more than 1 cm. Exclusion criteria: (a) hypersensitivity to drug or plant; (b) treatment with immunosuppressive drugs during the last month; (c) using systemic antibiotic during the last two weeks; (d) using anti-inflammatory drugs or anti-histamine during the last month; (e) using any drug for treatment of aphtous ulcers during the last 72 hours; (f) having systemic diseases such as endocrine, immunologic, hematologic, metabolic, rheumatoid arteritis, and hormonal disorders; (g) during pregnancy or breastfeeding; complete or partial denture or unsuitable restoration of a tooth or appliance ortodency in close contact with aphtous ulcers; (h) cigarette smoking or drinking alcohol; (i) affected with major aphtous ulcers or herpetiform ulcers. 15 years 60 years Both K12.0 Recurrent oral aphthae Treatment - Drugs Placebo putting 1 cm in length of Propolis gel on aphtous ulcers 4 time a day for 6 days putting 1 cm in length of orabase gel (placebo) on aphtous ulcers 4 time a day for 6 days Measuring the diameter of lesions. Timepoint: before and 3 and 6 days after treatment. Method of measurement: by physical examination. Measuring the pain severity. Timepoint: before and 3 and 6 days after treatment. Method of measurement: by taking history. Presence of erythema or exudates. Timepoint: 3 and 6 days after treatment. Method of measurement: by physical examination. Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences Approved 2014-11-25 Research Ethic Committee of Hamadan University of Medical Sciences Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Iran (Islamic Republic of)