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IRCT20120101008585N7 IRCT 2019-01-11 Shiraz University of Medical Sciences Evaluation the effect of dexamethasone mucoadhesive on oral lichen planus lesions Comparision the effect of dexamethasone mucoadhesive and triadent on the size and pain of oral lichen planus lesions 2018-12-31 anticipated 30 Complete https://irct.ir/trial/36415 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Each block with 4 allocations, consisting 2 allocation for intervention and 2 for control group will be considered. Six possible sequence of treatment allocation in each block will be listed and each one will be written on a card. Each time a block will be selected and the sequence of treatment will be registered until the treatment allocations become completed for all 30 participants (8 blocks). The randomization was performed by a methodologist. Allocation concealment will be done by the main researcher. On each 30 cards a sequence will be written and sealed. Pockets will be put in a box. A pocket will be allocated for each participant based on order of enrollment, Blinding description: The outcome assessor will be blinded to the type of prescribed medication. 2-3 Lichen planus. Intervention 1: Intervention group: The patient in intervention group will receive new designed dexamethasone mucoadhesive. This mucoadhesive will be used topically two times a day for 2 weeks and the next 2 weeks they will use the mucoadhesive once a day. The ointment will be retained for 5 minutes and then spitting. After breakfast and dinner mucoadhesive will be prescribed and the participants should refuse eating and drinking up to 30 minutes after application of Dexamethasone. Intervention 2: Control group: In this group patients will receive triadent 0.1% Razi company , 2 times a day for 2 weeks and the next 2 weeks they will use the mucoadhesive once a day. The ointment will be retained for 5 minutes and then spitting. After breakfast and dinner mucoadhesive will be prescribed and the participants should refuse eating and drinking up to 30 minutes after application of Triadent. Yes - There is a plan to make this available What will be shared: All collected data will be shared after deidentification of participants. When: 6 months after publication data will become available. To whom: The researchers in academic institutions Conditions: The researchers in academic institutions. Where to obtain: The researchers in academic institutions can email responsible person and request information How to obtain: The researchers in academic institutions can email responsible person and request information. Comments:
public Fatemeh Lavaee
Shiraz School of Dentistry, Ghasrdasht street, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7186781559 +98 71 3631 9309 lavaeef@sums.ac.ir Shiraz University of Medical Sciences scientific Fatemeh Lavaee
Shiraz School of Dentistry, Ghasrdasht street, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7186781559 +98 71 3631 9309 lavaeef@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) The patients with atrophic or erosive oral lichen planus The patients with histopathology and clinically conformed lichen planus The patients who will be referred to Oral and Maxillofacial Disease Department of Shiraz Dental School 18 years no limit Both The patients with history of other inflammatory diseases The patients with history of malignancies or even dysplastic lesions The patients who have received treatment for oral lichen planus lesions since a previous month pregnant women L43 Lichen planus Treatment - Drugs Treatment - Drugs Intervention group: The patient in intervention group will receive new designed dexamethasone mucoadhesive. This mucoadhesive will be used topically two times a day for 2 weeks and the next 2 weeks they will use the mucoadhesive once a day. The ointment will be retained for 5 minutes and then spitting. After breakfast and dinner mucoadhesive will be prescribed and the participants should refuse eating and drinking up to 30 minutes after application of Dexamethasone. Control group: In this group patients will receive triadent 0.1% Razi company , 2 times a day for 2 weeks and the next 2 weeks they will use the mucoadhesive once a day. The ointment will be retained for 5 minutes and then spitting. After breakfast and dinner mucoadhesive will be prescribed and the participants should refuse eating and drinking up to 30 minutes after application of Triadent. Pain. Timepoint: Week 1,2,4. Method of measurement: Visual analogue scale. Size. Timepoint: Week 1,2,4. Method of measurement: Scaled tongue blade(mm). Clinical presentation or inflammation. Timepoint: Week 1,2,4. Method of measurement: Thongprasom sign scoring. Shiraz University of Medical Sciences Approved 2018-12-25 Ethics committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences, Namazi square, Zand street, Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)