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IRCT20210519051341N1 IRCT 2021-09-23 Qazvin University of Medical Sciences A comparison between the Effectiveness of two different oral pastes, Containing Triamcinolone and Licorice, on minor Aphthous lesions: A triple blind randomized clinical trial A comparison between the Effectiveness of two different Oral pastes, containing Triamcinolone and Licorice, on Minor Aphthous lesions: A triple blind randomized clinical trial 2021-08-30 anticipated 60 Complete https://irct.ir/trial/57221 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided into three treatment groups A, B, C using the Balance block randomization method, the size of each block is 6 and the total number of blocks is 10. Balanced randomization allocation method for participants, in a randomized clinical trial study of the effect of Oral paste, containing Triamcinolone (group A), placebo (group B) and Licorice(group C) in reducing the size, pain and healing duration of the lesion. Randomization unit: individual Randomization tool: based on statistical software, Blinding description: These patients are divided into three groups of triamcinolone, Licorice and placebo (10 blocks of 6) based on random allocation. Patients in the first group are given triamcinolone gel under the brand name Triadent 10 grams (from Raha Daroo Company) three times a day, the second group is given an oral gel containing Licorice and the third group is given a placebo gel. The containers in which the drugs are placed are very similar to each other and the contents are unknown. This study is triple blind and the patient, researcher and statistician are unaware of the type of drug which is given. 3 Recurrent oral Aphthae. Intervention 1: Intervention group: Patients in the intervention group receive a drug containing the Licorice active ingredient. They are trained to apply the gel on the Aphthous lesion 3 times a day after brushing and to avoid eating and drinking for half an hour after that. The drug consists of the Licorice active ingredient with 5% concentration and Carboxymethyl Cellulose (CMC). Intervention 2: Standard treatment group: Triamcinolone (Trident 0.1%) is used as standard treatment. They should apply the oral paste on the Aphthous lesion 3 times a day after brushing and avoid eating and drinking for half an hour after that. Intervention 3: Control group: This group receives a placebo (containing no active substance). The placebo only consists of Carboxymethyl Cellulose (CMC). They should apply the placebo gel on the Aphthous lesion 3 times a day after brushing and avoid eating and drinking for half an hour after that. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Mahdie Zarabadipour
Department of Oral and maxillofacial medicine, school of dentistry, Qazvin University of Medical Sciences, Bahonar Blv, Qazvin
Qazvin Iran (Islamic Republic of) 3419915315 +98 28 3333 6001 mzarabadipour@qums.ac.ir Qazvin University of Medical Sciences scientific Mahdie Zarabadipour
Department of Oral and maxillofacial medicine, school of dentistry, Qazvin University of Medical Sciences, Bahonar Blv, Qazvin
Qazvin Iran (Islamic Republic of) 3419915315 +98 28 3333 6001 mzarabadipour@qums.ac.ir Qazvin University of Medical Sciences Iran (Islamic Republic of) Patients with Minor Aphthous ulcers who have been visited within the first 24 hours of incidence of the lesion. Patients do not have any systemic diseases ( Hypertension, Diabetes, Hyperlipidemia, Behcet disease, Rheumatism disease) Don't use medicine, cigarettes, alcohol and addiction 18 years 65 years Both An oral ulcer that is not an Aphthous lesion More than 48hrs passed from incidence of the lesion Allergic to herbal medicines Use of medicine, cigarettes, alcohol and addiction Systemic diseases K12.0 Recurrent oral Aphthae Treatment - Drugs Treatment - Drugs Placebo Intervention group: Patients in the intervention group receive a drug containing the Licorice active ingredient. They are trained to apply the gel on the Aphthous lesion 3 times a day after brushing and to avoid eating and drinking for half an hour after that. The drug consists of the Licorice active ingredient with 5% concentration and Carboxymethyl Cellulose (CMC). Standard treatment group: Triamcinolone (Trident 0.1%) is used as standard treatment. They should apply the oral paste on the Aphthous lesion 3 times a day after brushing and avoid eating and drinking for half an hour after that. Control group: This group receives a placebo (containing no active substance). The placebo only consists of Carboxymethyl Cellulose (CMC). They should apply the placebo gel on the Aphthous lesion 3 times a day after brushing and avoid eating and drinking for half an hour after that. Amount of pain. Timepoint: Before taking oral paste and the third, fifth and seventh days of treatment. Method of measurement: On the visit days, we ask the patient to mark the amount of pain on the Visual Analogue Scale. Healing duration. Timepoint: Before taking oral paste and the third, fifth and seventh days of treatment. Method of measurement: Days spent until complete healing of the lesion. Size of the lesion. Timepoint: Before taking oral paste and the third, fifth and seventh days of treatment. Method of measurement: The largest diameter of the lesion is measured with the dental probe in millimetres. Qazvin University of Medical Sciences Approved 2021-08-30 Ethics committee of Qazvin University of Medical Sciences Qazvin University of Medical Sciences, Bahonar Blv, Qazvin Qazvin Qazvin Iran (Islamic Republic of)