]>
IRCT2015080723542N1 IRCT 2015-09-12 Vice chancellor of Research and Technology of Zahedan University of Medical Sciences Effects of mucoadhesive paste contains olive leaf extract in the treatment of Recurrent Aphthous stomatitis (RAS) compared with topical corticosteroid Effects of mucoadhesive paste contains olive leaf extract in the treatment of Recurrent Aphthous stomatitis (RAS) compared with topical corticosteroid 2015-09-30 anticipated 26 Complete https://irct.ir/trial/20053 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2 Recurrent oral Aphthous. Intervention 1: Intervention group: mucoadhesive paste contains Olive leaf extract. Instruction of drug usage is 4 times per day, 3 times prior each meal and the last time, 20 min prior the sleeping. Evaluation and photography of ulcers are done in 0, 1, 2, 5 and 7th days from beginning of the experiment. Area of ulcer is estimated using Cavalieri’s point counting method and to evaluate pain, a visual analog scale (VAS) is used. Intervention 2: Positive control group:Tropical glucocorticoid (mucoadhesive paste contains triamcinolone) with the same instruction that used in interventional group. Intervention 3: Negative control group: mucoadhesive paste without any drug with the same instruction that used in interventional group.
public Dr. Zahra Heidari
School of Medicine, Zahedan University of Medical Sciences, Zahedan
Zahedan Iran (Islamic Republic of) 98168-43175 +98 54 3329 4390 histology@ymail.comhistology_iri@yahoo.com Zahedan University of Medical Sciences scientific Dr. Zahra Heidari
Histology department, School of medicine, Zahedan University of Medical Sciences, Zahedan
Zahedan Iran (Islamic Republic of) 98168-43175 +98 54 3329 4390 histology@ymail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: having 1-5 minor aphthous ulcer and their ulcers diameter were less than 5mm; having pain, without unusual sense of paresthesia and anesthesia; filling informed consent form for participation in this study. Exclusion criteria: having a history of drug hypersensitivity; pregnancy and breast feeding; having the history of systemic disorders or Behcet,s syndrome; receiving any other drug comprising NSAIDs or antihistamines in last 1 month; receiving any other drug for curing the ulcers from 72 hours prior the beginning the study; receiving systemic antibiotics from 2 weeks prior the beginning the study; Aphthous ulcers nearby trauma from sharp-edged teeth, broken restorations, orthodontic appliance or partial denture 18 years 70 years Both K12.0 Recurrent aphthous ulcer Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: mucoadhesive paste contains Olive leaf extract. Instruction of drug usage is 4 times per day, 3 times prior each meal and the last time, 20 min prior the sleeping. Evaluation and photography of ulcers are done in 0, 1, 2, 5 and 7th days from beginning of the experiment. Area of ulcer is estimated using Cavalieri’s point counting method and to evaluate pain, a visual analog scale (VAS) is used. Positive control group:Tropical glucocorticoid (mucoadhesive paste contains triamcinolone) with the same instruction that used in interventional group. Negative control group: mucoadhesive paste without any drug with the same instruction that used in interventional group. Surface of the ulcer. Timepoint: days 0, 1, 2, 5, and 7. Method of measurement: by stereological method of point counting method of cavalieri on ulcer photographs. Pain. Timepoint: days 0, 1, 2, 5, and 7. Method of measurement: VAS ruler of pain. Vice chancellor of Research and Technology of Zahedan University of Medical Sciences Approved 2015-08-02 Ethic committee of Zahedan University of Medical Sciences Pardis of Zahedan University of Medical Sciences Zahedan Iran (Islamic Republic of)