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

Determining the effect of combined treatment of clonazepam mouthwash and vitamin B1 and alphalipoic acid supplement in patients with burning mouth in people referred to the Faculty of Dentistry and affiliated hospitals of Tehran Islamic Azad University of Medical Sciences and Faculty of Dentistry of Shahid Beheshti University in the academic year 2023-2024

The clinical trial has a control group, with parallel groups, single blind, randomized, phase 3 on 54 patients, on 2 groups, each group includes 27 patients, rand function of Excel software was used for randomization.

The place of study: hospitals affiliated to Tehran Islamic Azad University of Medical Sciences and Faculty of Dentistry, Shahid Beheshti University of Medical Sciences. Study population: Patients with mouth burning (54 samples); Type of blinding: double blind in the form of identical packages which have meaningful codes for the statistical consultant and the researcher is unaware of the type of treatment provided and the patients are unaware of the type of treatment received.

Inclusion criteria: Patients with healthy systemic conditions; having burning sensation in the mouth for more than 2 hours a day in 50% of the day and night hours and for a period of more than 3 months. Non-inclusion criteria: the presence of any clinical lesions of the pharynx and nose, any type of local or systemic factor, use of chemical drugs, hypersensitivity reactions, complete dental prosthesis, bad oral habits such as teeth grinding, mucosal diseases mouth such as lichen planus, benign migratory glossitis and bacterial, fungal and viral infections

Intervention group: Clonazepam mouthwash; Control group: clonazepam mouthwash, vitamin B1 supplement and alpha lipoic acid

The amount of mouth burning

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.

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.

All data is potentially shareable after de-identifying individuals

The access period starts 6 months after the results are published

Researchers working in academic and scientific institutions and people who are also engaged in industry

They are allowed to use documents only if they use references.

Ali Moghadasi; 09190903027; Department of Oral and Dental Diseases; Department of Dentistry; Tehran Islamic Azad University

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