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IRCT20231213060357N1 IRCT 2024-02-17 Shiraz University of Medical Sciences Effectiveness of micro-needling for oral lichen planus treatment Effectiveness of micro-needle assisted transmucosal delivery of hyaluronic acid and triamcinolone for oral lichen planus treatment 2024-03-05 anticipated 10 Complete https://irct.ir/trial/74847 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: 10 patients with bilateral lichen planus lesions will participate in this study. These patients will be divided into two groups with 5 subjects and the effectiveness of four different treatment plans will be determined and compared with each other. In this way, first the patients are randomly attributed to one of the two groups A or B, and then two different treatment plans will be performed in each patient with bilateral lesions. Therefore, two different treatment subgroups are defined in each group.The sample size estimation will be calculated based on a pilot study of 5 subjects in each group (A or B) at the 5% level of significance with power of 90%, Randomization description: The random allocation will be performed using a computer random number generator to create a random number table. In more detail, subjects will be randomly attributed ۰ (group A) or ۱ (group B). Thereafter, lesions on the right side will be randomly attributed ۰ (G۱ in group A or G۳ in group B) or 1 (G۲ in group A or G4 in group B), Blinding description: Patients and the intervention provider will aware of the treatment type, but to establish a blind evaluation, the scores for the parameters such as pain level and severity of lesions will be determined by two oral medicine specialists who will not involve in any step during patients' allocation, treatment delivery and micro needling. Therefore, they will be blinded to the type of intervention and study period. On the other hand, an independent statistician will perform the statistical analysis. It is important to note that every groups and the study subjects will have a code number to ensure his/her blinding (statistician). Therefore, this study will be double blind. 3 Oral Lichen Planus. Intervention 1: Control group G 1: Control side in group A will be received topical 0.1% triamcinolone acetonide suspension (Exir, Iran) twice a day as the first line treatment during the study (for two months). Prophylactic antifungal therapy (fluconazole 200 mg once weekly) will be also prescribed during the study. Intervention 2: Intervention group G 2: Micro-needling (MN) side in group A will be subjected to MN once a week for two weeks and then received topical application of 0.1% triamcinolone acetonide (TA) suspension (Exir, Iran). Topical application of 0.1% TA twice a day for two months and prophylactic antifungal therapy (fluconazole 200 mg once weekly) will be also prescribed during the study. Intervention 3: Intervention group G 3: Hyaluronic acid (HA) side in group B will be received topical 0.2% HA (Gengigel, Ricerfarma, Italy) twice a day for two weeks. Topical application of 0.1% triamcinolone acetonide suspension (Exir, Iran) twice a day for two months and prophylactic antifungal therapy (fluconazole 200 mg once weekly) will be also prescribed during the study. Intervention 4: Intervention group G 4: Combination side in group B will be subjected to MN once a week for two weeks and then received topical 0.2% Hyaluronic acid (HA) (Gengigel, Ricerfarma, Italy) and 0.1% triamcinolone acetonide (TA) suspension (Exir, Iran). Topical application of topical 0.2% HA twice a day for two weeks, 0.1% TA suspension twice a day for two months, and prophylactic antifungal therapy (fluconazole 200 mg once weekly) will be also prescribed during the study. Yes - There is a plan to make this available What will be shared: Data can be shared after de-identifying individuals. When: Data will be available up to 6 months after publication. To whom: The researchers in academic and scientific institutions Conditions: The researchers in academic and scientific institutions Where to obtain: The data supporting the findings of this study will be available upon reasonable request from the corresponding author. How to obtain: The researchers in academic and scientific institutions can email the corresponding author and request for information. Comments:
public Asma Sookhakian
Shiraz School of Dentistry, Ghasrodasht street
Shiraz Iran (Islamic Republic of) 7195615878 +98 71 3628 0112 asma.soukhakian@gmail.com Shiraz University of Medical Sciences scientific Maryam Zahed
Shiraz School of Dentistry, Ghasrodasht street
Shiraz Iran (Islamic Republic of) 7195615878 +98 71 3628 0112 maryamzhd@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Subjects aged 18 years or older Subjects diagnosed with OLP based on the clinical or histopathological findings according to the newest diagnostic approach published by American Academy of Oral and Maxillofacial Pathology in ۲۰۱۶ Subjects with bilateral symptomatic OLP lesions Subjects who are willing to complete this clinical trial 18 years no limit Both Subjects with lesions that may be associated with lichenoid reactions Subjects having a history of drug allergy Subjects with a history of use of topical corticosteroids (in the past ۴ weeks) or systemic corticosteroids (in the past ۳ months) for oral lichen planus, other immunosuppressive treatments, retinoids, and anticoagulants Subjects having oral candidiasis Subjects with self-reported pregnancy or lactation L43 Lichen planus N/A Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group G 1: Control side in group A will be received topical 0.1% triamcinolone acetonide suspension (Exir, Iran) twice a day as the first line treatment during the study (for two months). Prophylactic antifungal therapy (fluconazole 200 mg once weekly) will be also prescribed during the study. Intervention group G 2: Micro-needling (MN) side in group A will be subjected to MN once a week for two weeks and then received topical application of 0.1% triamcinolone acetonide (TA) suspension (Exir, Iran). Topical application of 0.1% TA twice a day for two months and prophylactic antifungal therapy (fluconazole 200 mg once weekly) will be also prescribed during the study. Intervention group G 3: Hyaluronic acid (HA) side in group B will be received topical 0.2% HA (Gengigel, Ricerfarma, Italy) twice a day for two weeks. Topical application of 0.1% triamcinolone acetonide suspension (Exir, Iran) twice a day for two months and prophylactic antifungal therapy (fluconazole 200 mg once weekly) will be also prescribed during the study. Intervention group G 4: Combination side in group B will be subjected to MN once a week for two weeks and then received topical 0.2% Hyaluronic acid (HA) (Gengigel, Ricerfarma, Italy) and 0.1% triamcinolone acetonide (TA) suspension (Exir, Iran). Topical application of topical 0.2% HA twice a day for two weeks, 0.1% TA suspension twice a day for two months, and prophylactic antifungal therapy (fluconazole 200 mg once weekly) will be also prescribed during the study. Pain Level. Timepoint: At the beginning of the study (before the start of the intervention) and 14, 28, and 56 days after start. Method of measurement: Visual Analogue Scale. Severity of the lesions. Timepoint: At the beginning of the study (before the start of the intervention) and 14, 28, and 56 days after start. Method of measurement: reticulation/erythema/ ulceration (REU) scoring system. Shiraz University of Medical Sciences Approved 2023-12-20 Research Ethics Committee of School of Dentistry-Shiraz University of Medical Sciences Shiraz University of Medical Science, Zand street Shiraz Fars Iran (Islamic Republic of)