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IRCT20230413057893N1 IRCT 2023-05-31 Islamic Azad University Efficiency of combined treatment of clonazepam mouthwash and vitamin B1 and alphalipoic acid supplements in the treatment of idiopathic burning mouth Comparison of the effectiveness of clonazepam mouthwash and the combined treatment of clonazepam mouthwash, vitamin B1 and alphalipoic acid supplements on burning of mouth in patients with idiopathic burning mouth 2023-06-22 anticipated 54 Complete https://irct.ir/trial/69670 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is done using random blocks of size 4. In these random blocks of 4, 2 samples are treated with clonazepam mouthwash alone and 2 samples are treated with clonazepam mouthwash and vitamin B1 and alpha lipoic acid supplements. The randomization process is done by Excel software. The type of treatment that the patient will receive is placed in envelopes numbered from 1 to 54 (according to the number of samples). In this way, from the first 4 patients, 2 patients will be treated with mouthwash alone and 2 patients will be treated with mouthwash and their supplements. This process is done by the statistics consultant and they will not open the envelopes until the treatment process starts, Blinding description: The drug and placebo are divided into the same packages with specific and meaningful codes for the statistical consultant, and the researcher and the patient are not aware of the type of drug in each package. 3 Idiopathic burning mouth. Intervention 1: Control group: These patients are given mouthwash containing clonazepam 0.5 mg/1 cc and are asked to gargle and spit 5 cc after each meal for 2-4 minutes, 3 times a day for 28 days. Intervention 2: Intervention group: Patients are given and asked for mouthwash containing clonazepam 0.5 mg/1 cc. After each meal, gargle and spit 5 cc of this medicine for 2-4 minutes for 3 times a day. In addition, vitamin B1 tablets (300 mg) twice a day and alpha lipoic acid tablets 200 mg three times a day are prescribed for them to take for 28 days. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions and people who are also engaged in industry Conditions: They are allowed to use documents only if they use references. Where to obtain: Ali Moghadasi; 09190903027; Department of Oral and Dental Diseases; Department of Dentistry; Tehran Islamic Azad University How to obtain: Submitting the request and clarifying the purpose of the request. If approved, the information will be provided to the applicant Comments:
public Ali Moghadasi
No 4, Shahed Street
Tehran Iran (Islamic Republic of) 1473685686 +98 21 4407 4766 am.alimoghadasi@yahoo.com Islamic Azad University scientific Ali Moghadasi
Unit 4; No 4; Shahed street; East Payambar; Ashrafi Esfahani Blvd
Tehran Iran (Islamic Republic of) 1473685686 +98 21 4407 4766 am.alimoghadasi@yahoo.com Islamic Azad University Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with healthy systemic conditions Patients who feel oral burning more than 2 hours a day in 50% of the day and night and more than 3 months. 16 years 89 years Both The presence of any lesions of the pharynx and nose from a clinical point of view the use of chemical drugs hypersensitivity reactions physical or chemical factors complete dental prosthesis bad oral habits such as teeth grinding oral mucosa disease such as lichen planus benign migratory glossitis bacterial, fungal and viral infections Dry mouth primary or secondary to salivary gland disorders or after radiation therapy neurological problems endocrine disorders digestive diseases malnutrition Pregnancy/lactation sensitivity to clonazepam Treatment - Drugs Treatment - Drugs Control group: These patients are given mouthwash containing clonazepam 0.5 mg/1 cc and are asked to gargle and spit 5 cc after each meal for 2-4 minutes, 3 times a day for 28 days. Intervention group: Patients are given and asked for mouthwash containing clonazepam 0.5 mg/1 cc. After each meal, gargle and spit 5 cc of this medicine for 2-4 minutes for 3 times a day. In addition, vitamin B1 tablets (300 mg) twice a day and alpha lipoic acid tablets 200 mg three times a day are prescribed for them to take for 28 days. The degree of mouth burning. Timepoint: Day zero, fourteen and twenty eight. Method of measurement: visual analogue scaling. Islamic Azad University Approved 2023-04-10 Ethics committee of Department of Dentistry, Tehran Azad University No. 9, Nistan 9th, Pasdaran Street Tehran Tehran Iran (Islamic Republic of)