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IRCT20080907001222N2 IRCT 2019-03-11 Mashhad University of Medical Sciences Comparison of therapeutic effect of nigella sativa and corticosterioid in orabase on oral erosive atrophic lichen planus Comparison of therapeutic effect of nigella sativa and corticosterioid in orabase on oral erosive atrophic lichen planus:A randomized triple blind clinical trial 2640-06-22 anticipated 40 Pending https://irct.ir/trial/37981 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, patients are randomly divided into two groups. Randomization is performed Based on the random numbers table obtained from www.randomizer.org. Even number will be allocated in intervention group and odd number in control group, Blinding description: Two orabase will be made completely the same ,for taste and color similarity we will add sub therapeutic dose of nigella sativa and color to orabase in control group so patients,outcome assessor and data analyser will be blind to drug type. 1-2 lichen planus. Intervention 1: In intervention group patients will use nigella sativa orabase (5%) 3 times a day for one month. Intervention 2: Control group: In this group patients will receive routine treatment which is orabase containing corticosteroid (Triamcinolone 0-1%) 3 time a day topically for one month. Yes - There is a plan to make this available What will be shared: No- There is no plan to make this available at the present time When: starting 9 months after publication To whom: academic researchers Conditions: It is permitted to use the data in other studies with reference. Where to obtain: pakfetrata@mums.ac.ir How to obtain: Sending email to authors. the authors will send data via email during 4 weeks. Comments:
public Atessa Pakfetrat
Department of Oral Medicine, School of Dentistry, Mashhad University of Medical Sciences, Vakilabad Blv
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 pakfetrata@mums.ac.ir Mashhad University of Medical Sciences scientific Atessa Pakfetrat
Department of Oral Medicine, School of Dentistry, Mashhad University of Medical Sciences, Vakilabad Blv
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 pakfetrata@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) patient with oral lichen planus two oral lesions maximum 3 cm diameter 8 years no limit Both systemic compromised patients lesion of posterior palate and oral floor pregnant and breast feeding patients children under 8 years old patients using immunosuppressant drugs lichenoid reaction lesions nigella sativa hypersensitivity L43 Lichen planus Treatment - Drugs Treatment - Drugs In intervention group patients will use nigella sativa orabase (5%) 3 times a day for one month Control group: In this group patients will receive routine treatment which is orabase containing corticosteroid (Triamcinolone 0-1%) 3 time a day topically for one month. Severity of oral lesion. Timepoint: weekly up to one month. Method of measurement: tongprasom scale. Burning sensation. Timepoint: Pain and burning sensation will be measured before intervention and then weekly for one month. Method of measurement: Visual Analogue Scale. Mashhad University of Medical Sciences Approved 2018-12-19 Ethic Committee of Mashhad medical university Mashhad University of Medical Sciences,Faculty of Dentistry Mashhad Razavi Khorasan Iran (Islamic Republic of)