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IRCT20250106064298N1 IRCT 2025-02-18 Tabriz University of Medical Sciences Effect of Gamma-oryzanol in Lichen Planus Comparison of the Effect of Gamma-oryzanol Mucoadhesive paste with Betamethasone Mouthwash and Betamethasone Mouthwash Alone on Clinical Manifestations and Pain Severity in Oral Lichen Planus Patients 2025-02-19 anticipated 38 Complete https://irct.ir/trial/81335 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After selecting eligible patients, randomization will be done by envelope method and divided into two groups with equal distribution of groups. Patients are matched in terms of age and sex, and the third researcher will perform randomization. A third investigator will not participate in any assessment during or after treatment. The study group (case or control) will be placed inside identical envelopes marked with consecutive numbers. Envelopes will be sealed until treatment begins, Blinding description: Two drugs are prepared and assigned in the same form and in the same envelopes to the number of members of each group by a trained third person from number 1 to 38 for two groups so that none of the researchers and patients know about the contents of the package. 3 Symptomatic oral lichen planus lesions. Intervention 1: Intervention group: At the beginning, plastic base is prepared. This base is made of polyethylene and liquid paraffin, with the explanation that polyethylene is added to liquid paraffin at the rate of 5% by weight and it melts and dissolves by heating the paraffin. Then it is spread in a thin layer on cold metal plates. By cooling the plastic base, the base is formed. Gamma-oryzanol is added by geometrical method, that is, its small amounts are mixed with small amounts of base up to larger amounts in a mortar. Its larger amounts are put under a mechanical stirrer to ensure the uniformity of gamma-oryzanol distribution in the base. In the next step, the components of the adhesive mucus, i.e. pectin, gelatin and sodium carboxymethyl cellulose, are added to the base with a ratio of one third each and their total ratio to the base with an equal ratio using the geometrical addition method under a mechanical stirrer. Care should be taken to ensure that water does not enter the formulation at all stages. It means to use completely dry dishes. It is better to completely dehydrate these mucous adhesive materials, i.e. pectin, gelatin and sodium carboxymethyl cellulose, before adding them to the formula for 1 day in a 60 degree oven. The prepared formulation is filled in tubes and their containers are closed and stored in a dry environment, preferably a desiccator, until use by the patient. After brushing and then using betamethasone mouthwash, patients will receive gamma-oryzanol adhesive mucus for 8 weeks. Mouthwash followed by adhesive mucus will be used three times a day. Patients will be followed up 4, 8 and 12 weeks later. The evaluated parameters will include clinical score based on Thongprasom's scale and pain using VAS. Patients will be taught how to use drugs. Intervention 2: Control group: Patients in this group will use the standard routine treatment regimen. Betamethasone mouthwash is used for 8 weeks after brushing. Mouthwash will be used three times a day. Patients will be followed up 4, 8 and 12 weeks later. The evaluated parameters will include clinical score based on Thongprasom's scale and pain using VAS. Patients will be taught how to use drugs. Yes - There is a plan to make this available What will be shared: Participant data file, information related to the main outcome When: 18 months after the study To whom: Data is published Conditions: In case of citation Where to obtain: Sara hasannejad, sarahasannejad9801@gmail.com How to obtain: By communicating with the person in charge of the update Comments:
public Maryam Kooh Soltani
Faculty of Dentistry, Tabriz University of Medical Sciences, Golgasht St., Tabriz
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3334 0310 mkoohsoltani@yahoo.com Tabriz University of Medical Sciences scientific Maryam Kooh Soltani
Faculty of Dentistry, Tabriz University of Medical Sciences, Golgasht St., Tabriz
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3334 0310 mkoohsoltani@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of Oral Lichen Planus based on clinical and histopathological findings of patients with at least one visible and measurable ulcerative or atrophic or reticular Oral Lichen Planus lesion Patients who have not received immunosuppressive drugs Absence of dysplasia Absence of underlying disease Completeness of the file including demographic and clinical information 18 years no limit Both Allergy to betamethasone or gamma-oryzanol mouthwash There are only reticular lines in the patient's mouth and the lichen planus is painless The presence of uncontrolled diabetes Blood pressure and other underlying diseases that can interfere with participation and compliance with the study Immunosuppression Hepatitis (because corticosteroid suppresses the immune system and increases the likelihood of viremia) The use of lichenoid reaction drugs or the presence of amalgam repair in the vicinity of the lesion The presence of skin or other mucosal destruction lesions Patients with oral candidiasis Receiving treatment for oral lichen planus in the past 12 weeks Viral infections Pregnancy and breastfeeding L43.8 Other lichen planus Treatment - Drugs Treatment - Drugs Intervention group: At the beginning, plastic base is prepared. This base is made of polyethylene and liquid paraffin, with the explanation that polyethylene is added to liquid paraffin at the rate of 5% by weight and it melts and dissolves by heating the paraffin. Then it is spread in a thin layer on cold metal plates. By cooling the plastic base, the base is formed. Gamma-oryzanol is added by geometrical method, that is, its small amounts are mixed with small amounts of base up to larger amounts in a mortar. Its larger amounts are put under a mechanical stirrer to ensure the uniformity of gamma-oryzanol distribution in the base. In the next step, the components of the adhesive mucus, i.e. pectin, gelatin and sodium carboxymethyl cellulose, are added to the base with a ratio of one third each and their total ratio to the base with an equal ratio using the geometrical addition method under a mechanical stirrer. Care should be taken to ensure that water does not enter the formulation at all stages. It means to use completely dry dishes. It is better to completely dehydrate these mucous adhesive materials, i.e. pectin, gelatin and sodium carboxymethyl cellulose, before adding them to the formula for 1 day in a 60 degree oven. The prepared formulation is filled in tubes and their containers are closed and stored in a dry environment, preferably a desiccator, until use by the patient. After brushing and then using betamethasone mouthwash, patients will receive gamma-oryzanol adhesive mucus for 8 weeks. Mouthwash followed by adhesive mucus will be used three times a day. Patients will be followed up 4, 8 and 12 weeks later. The evaluated parameters will include clinical score based on Thongprasom's scale and pain using VAS. Patients will be taught how to use drugs. Control group: Patients in this group will use the standard routine treatment regimen. Betamethasone mouthwash is used for 8 weeks after brushing. Mouthwash will be used three times a day. Patients will be followed up 4, 8 and 12 weeks later. The evaluated parameters will include clinical score based on Thongprasom's scale and pain using VAS. Patients will be taught how to use drugs. Clinical score based on Thongprasom's scale. Timepoint: At the beginning of the intervention, 4 weeks later, 8 weeks later, 12 weeks later. Method of measurement: The clinical score will be calculated based on Thongprasom's scale: grade 0 = no lesion / normal mucosa grade 1 = white striae / no erythematous area grade 2 = white striae with an atrophic area equal to or less than 1 cm2 grade 3 = white striae with area Atrophic more than 1 cm2 grade 4 = white stretch marks with erogenous area equal to or less than 1 cm2 grade 5 = white stretch marks with erogenous area more than 1 cm square meter. Pain score using Visual Analogue Scale. Timepoint: At the beginning of the intervention, 4 weeks later, 8 weeks later, 12 weeks later. Method of measurement: Pain will be evaluated using the VAS (Visual Analogue Scale) scale, which includes a 10 cm horizontal line from 0 = no pain, to 10 = the most severe pain experienced, and the patient chooses a number based on the pain intensity. Tabriz University of Medical Sciences Approved 2024-12-29 Ethics Committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Golgasht St., Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)