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IRCT20241114063707N1 IRCT 2024-11-25 Tabriz University of Medical Sciences Comparision of the efficacy of two treatment methods including baicalin mucoadhesive paste with betamethasone mouthwash and betamethasone mouthwash alone in patients with oral lichen planus Comparision of the efficacy of two treatment methods including baicalin mucoadhesive paste with betamethasone mouthwash and betamethasone mouthwash alone in patients with oral lichen planus 2024-12-20 anticipated 36 Complete https://irct.ir/trial/80188 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 18 intervention envelopes and 18 control envelopes, which are identical , will be randomly numbered from 1 to 36. The randomization process will be done manually. The envelopes will remain sealed until the treatment begins. The distribution of the envelopes will follow the order of the patients on the list. Patients will be matched based on age and gender, and one of the researchers, who is aware of the treatment administered to the patient, will answer any questions the patients may have, Blinding description: Eligible patients will be randomized into two groups. In this study, blinding will be done in such a way that the third researcher will be unaware of the treatment used for the patient and will only perform measurements and determine the clinical score. The questions of the patients will be answered by one of the researchers who is in the course of the treatment done for the patient. The third researcher and statistical analyst will be unaware of the content of the prescribed drug. 3 oral lichen planus. Intervention 1: Intervention group: Mucoadhesive baicalin with betamethasone mouthwash in patients with oral lichen planus. First, the plastibase base is prepared. This base is made of polyethylene and liquid paraffin, with the explanation that polyethylene is added to liquid paraffin at a rate of 5% by weight and volume, and the paraffin is melted and dissolved by heating. Then, it is spread on cold metal plates as a thin layer. When the plastibase base cools, it is formed. Baicalin is mixed with small amounts of base in a mortar and pestle using the geometric addition method, i.e., small amounts are mixed with small amounts of base to larger amounts in a mortar. Large amounts are placed under a mechanical stirrer to ensure the uniformity of baicalin distribution in the base. In the next step, the components of the mucoadhesive, namely pectin, gelatin, and sodium carboxymethyl cellulose, are added to the base in a ratio of one-third each and their total ratio to the base in a ratio equal to the geometric addition method under a mechanical stirrer. Care must be taken not to introduce water into the formulation at all stages. That is, completely dry containers should be used. It is better to completely dehydrate these mucoadhesive materials, namely pectin, gelatin and sodium carboxymethyl cellulose, in a 60 degree oven for 1 day before adding to the formula. The prepared formulation is filled in tubes and their containers are closed and stored in a dry environment, preferably a desiccator, until the patient uses it. Patients will receive baicalin mucoadhesive after brushing their teeth and then using betamethasone mouthwash. The mouthwash and then the mucoadhesive will be used three times a day. Patients will be followed up 2 and 4 weeks later. The parameters evaluated will include clinical scores based on Thongprasom’s scale and pain using VAS. Patients will be given instructions on how to use the medications. Intervention 2: Control group: Betamethasone mouthwash in patients with oral lichen planus: Standard routine treatment regimen will be used. Betamethasone mouthwash will be used three times a day. Patients will be followed up 2 and 4 weeks later. The parameters evaluated will include clinical score based on Thongprasom’s scale and pain using VAS. Patients will be given instruction on how to use the medications. Yes - There is a plan to make this available What will be shared: Participants data file When: 18 months after the study To whom: Data is published Conditions: In case of citation Where to obtain: Mohadese Eslamzade Hesari m.eslamzade.d.s@gmail.com How to obtain: By communicating with the person in charge of the update Comments:
public Maryam Kouhsoltani
Attar street, Golgasht, Azadi Blv., Tabriz
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3334 0310 mkoohsoltani@yahoo.com Tabriz University of Medical Sciences scientific Maryam Kouhsoltani
Attar street, Golgasht, Azadi Blv., Tabriz
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3334 0310 mkoohsoltani@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients with definite diagnosis of oral lichen planus based on clinical and histopathological findings Patients with at least one visible and measurable ulcerative or atrophic or reticular lichen planus lesion. Adult patients (over 18 years old) Patients who do not receive immunosuppressive drugs Patients without underlying disease Patients with complete records including clinical and demographic information 18 years no limit Both Smoking, alcohol consumption, caffeine The presence of uncontrolled diabetes, hypertension and other underlying diseases that hinder participation in the study Immune system suppression Presence of other simultaneous skin or mucosal lesions Received treatment for oral lichen planus in the last 12 weeks Patients with oral candidiasis Viral infections Lesions showing any dysplastic changes. Unwillingness to participate in the study L43.8 Other lichen planus Treatment - Drugs Treatment - Drugs Intervention group: Mucoadhesive baicalin with betamethasone mouthwash in patients with oral lichen planus. First, the plastibase base is prepared. This base is made of polyethylene and liquid paraffin, with the explanation that polyethylene is added to liquid paraffin at a rate of 5% by weight and volume, and the paraffin is melted and dissolved by heating. Then, it is spread on cold metal plates as a thin layer. When the plastibase base cools, it is formed. Baicalin is mixed with small amounts of base in a mortar and pestle using the geometric addition method, i.e., small amounts are mixed with small amounts of base to larger amounts in a mortar. Large amounts are placed under a mechanical stirrer to ensure the uniformity of baicalin distribution in the base. In the next step, the components of the mucoadhesive, namely pectin, gelatin, and sodium carboxymethyl cellulose, are added to the base in a ratio of one-third each and their total ratio to the base in a ratio equal to the geometric addition method under a mechanical stirrer. Care must be taken not to introduce water into the formulation at all stages. That is, completely dry containers should be used. It is better to completely dehydrate these mucoadhesive materials, namely pectin, gelatin and sodium carboxymethyl cellulose, in a 60 degree oven for 1 day before adding to the formula. The prepared formulation is filled in tubes and their containers are closed and stored in a dry environment, preferably a desiccator, until the patient uses it. Patients will receive baicalin mucoadhesive after brushing their teeth and then using betamethasone mouthwash. The mouthwash and then the mucoadhesive will be used three times a day. Patients will be followed up 2 and 4 weeks later. The parameters evaluated will include clinical scores based on Thongprasom’s scale and pain using VAS. Patients will be given instructions on how to use the medications. Control group: Betamethasone mouthwash in patients with oral lichen planus: Standard routine treatment regimen will be used. Betamethasone mouthwash will be used three times a day. Patients will be followed up 2 and 4 weeks later. The parameters evaluated will include clinical score based on Thongprasom’s scale and pain using VAS. Patients will be given instruction on how to use the medications. Clinical score based on Thongprasom scale. Timepoint: At the beginning of the intervention, 2 weeks later, 4 weeks later. Method of measurement: The clinical score will be based on Thongprasom's scale : Grade 0 = no lesion / normal mucosaGrade 1 = white striae / no erythematous areaGrade 2 = white striae with an atrophic area equal to or less than 1 cm2Grade 3 = white striae with an atrophic area greater than 1 cm2Grade 4 = white striae with an erogenous area equal to or less than 1 cm2Grade 5 = white striae with an erogenous zone greater than 1 cm2. Pain based on Visual Analogue Scale(VAS). Timepoint: At the beginning of the intervention, 2 weeks later, 4 weeks later. Method of measurement: Pain will be evaluated using the Visual Analogue Scale including a 10 cm horizontal line (0 = no pain, 10 = the most severe pain experienced). Tabriz University of Medical Sciences Approved 2024-08-19 Ethics committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Attar street, Golgasht, Azadi Blv. Tabriz East Azarbaijan Iran (Islamic Republic of)