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IRCT20171017036835N2 IRCT 2018-03-08 Mashhad University of Medical Sciences The effect of vitamin D on oral lichen planus The evaluation of oral vitamin D on improvement of patients with oral erosiver-atrophic lichen planus: Double blind randomized clinical trial 2018-03-23 anticipated 28 Complete https://irct.ir/trial/27430 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: seal envelope, Blinding description: 1. pearl Vit D (A) and placebo (B) are made in similar capsules by pharmacologist. 2. capsules are placed in some paper packs. 3. seal envelope will be used to randomize. 4. Participants and care providers and assessing outcomes and statistician are blinded to type of drug. 2-3 Oral lichen planus. Intervention 1: After laboratory tests, for intervention patients(13 patients), 2-3 times a day, a dexamethasone mouthwash and nystatin mouthwash (Jaber ebne Hayan Company) will be prescribed, for 8 weeks. Additionally, vitamin D capsules 50000IU (manufactured by Dana Pharmaceutical Company) will be prescribed, one pearl every week, for 8 weeks. Also, the patients will be evaluated according to pain and burning and type and severity of the lesions . Cytokines and Vit D levels will be assessed before and two months after treatment. Intervention 2: After laboratory tests, for control group,(15 patients), 2-3 times a day, a dexamethasone mouthwash and nystatin mouthwash (Jaber ebne Hayan Company) will be prescribed, for 8 weeks. Additionally, placebo capsules filled with lactose and in the same weight of vitamin D capsuls will be prescribed, one capsule every week, for 8 weeks. Also, the patients will be evaluated according to pain and burning and type and severity of the lesions . Cytokines and Vit D levels will be assessed before and two months after treatment. Yes - There is a plan to make this available What will be shared: Some data including demographic properties, signs and symptoms, Vit D and cytokines levels. When: two months after article publication. To whom: academic researchers Conditions: It is permitted to use the data in other studies with reference. Where to obtain: Dr. Asieh Rahimi email: dr.rahimi.79@gmail.com How to obtain: sending email to authors. the authors will send data via email during 4 weeks. Comments:
public Asieh Rahimi
Mashhad Dental School
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 dr.rahimi.79@gmail.com Mashhad University of Medical Sciences scientific Zahra Delavarian
Mashhad Dental School
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 delavarianz@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 1. Patients with erosive-atrophic oral lichen planus with confirmation of clinical diagnosis and histopathology confirmation. 2. Patients have not used any systemic or topical drug for the treatment of lichen planus over the past 2 weeks. 3. In the past 3 months, they have not used any vitamin supplements. 4. Patients aged 18-80 years old were considered. 5. People with vitamin D deficiency or insufficiency (25 (OH) D <30 mg / dl). 6. Patients with grade 2 to 5 Thongprosam criteria will enroll in this study. 18 years 80 years Both 1. People who have been diagnosed with , mild to severe dysplasia. 2. Calcium levels above 10 mg / dl, phosphorus less than 2.5 mg / dl (rejection of hyperparathyroidism) 3. lichenoid reaction. 4. Patients who do not have the necessary co-operation or attending the control sessions. 5. Pregnant women 6. Metabolic bone diseases such as: osteomalacia and primary hyperparathyroidism (with endocrinologist confirmation) 7. Patient with a history of severe renal-hepatic dysfunction 8. Chronic inflammatory disease in addition to lichen planus 9. If you have a history of being allergic to vitamin D supplements (itching, inflammation or redness in the skin and cramps, then using the supplementation of this vitamin) 10. Patients who use barbiturates and phenytoin. 11. Patients with granulomatous diseases, including sarcoidosis 12. History of malabsorption or chronic pancreatitis L43 Lichen planus Treatment - Drugs Placebo After laboratory tests, for intervention patients(13 patients), 2-3 times a day, a dexamethasone mouthwash and nystatin mouthwash (Jaber ebne Hayan Company) will be prescribed, for 8 weeks. Additionally, vitamin D capsules 50000IU (manufactured by Dana Pharmaceutical Company) will be prescribed, one pearl every week, for 8 weeks. Also, the patients will be evaluated according to pain and burning and type and severity of the lesions . Cytokines and Vit D levels will be assessed before and two months after treatment. After laboratory tests, for control group,(15 patients), 2-3 times a day, a dexamethasone mouthwash and nystatin mouthwash (Jaber ebne Hayan Company) will be prescribed, for 8 weeks. Additionally, placebo capsules filled with lactose and in the same weight of vitamin D capsuls will be prescribed, one capsule every week, for 8 weeks. Also, the patients will be evaluated according to pain and burning and type and severity of the lesions . Cytokines and Vit D levels will be assessed before and two months after treatment. Burning and pain. Timepoint: every 2 week for 2 months. Method of measurement: visual analogue scale. Size and severity of lesion. Timepoint: every 2 week for 2 months. Method of measurement: thongprasom. Cytokines TNF-α and IL-6. Timepoint: before treatment and 2 month later. Method of measurement: ELISA. Mashhad University of Medical Sciences Approved 2015-09-09 Mashhad University of Medical Sciences- Research Ethics Committee Vice chancellor of research, MUMS (Mashhad University of Medical Sciences) Mashhad Razavi Khorasan Iran (Islamic Republic of)