Patients with oral lichen planus. Lichen planus, unspecified
Conditions
Interventions
Intervention 1: **Intervention Group:**This group receives only nanocurcumin (Sinacurcumin capsules, 80 mg). The soft gelatin capsule contains nanomicelles of curcumin and is taken once daily after br
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Definitive Diagnosis of Erosive/Atrophic Lichen Planus: Based on the Modified WHO Classification Criteria Lesion severity in the patient must be scored as 2 or higher based on the Thongprasom criteria. The patient must fall under ASA physical status classification I or II in terms of systemic health. The CFU count obtained from the dorsal surface of the tongue must exceed 500 CFU/g. Informed consent to participate in the study. No history of drug hypersensitivity: patients must not have any history of allergic reactions to the medications used in the study. Ability and willingness to cooperate: including the ability to take medications regularly and attend follow-up visits. Absence of local or systemic predisposing factors for candidiasis, such as the use of inhaled or topical corticosteroids, presence of hyperkeratosis, use of immunosuppressive drugs, etc. No history of systemic antibiotic use within two weeks prior to the start of the study. No use of systemic or topical antifungal agents for any reason. No history of topical corticosteroid use within two weeks prior to the start of the study. Women must not be pregnant or breastfeeding during the study period. No use of dentures or orthodontic appliances. No tobacco use. No history of turmeric allergy.
Exclusion criteria
Exclusion criteria: Likelihood of Lichenoid Reaction Based on Clinical Presentation, Histopathology, and the Modified WHO Classification Criteria Occurrence of severe adverse effects: In the event of any severe side effects, the patient will be withdrawn from the study Pregnancy during the course of the study Development of allergic reactions to the prescribed medications during the study period Failure to complete the treatment course for any reason, including participant withdrawal from the study or non-adherence to the treatment protocol Failure to meet the previously stated inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in CFU count (Candida colony-forming units). Timepoint: Assessments will be conducted before treatment, and at weeks 1, 2, and 4. Method of measurement: Before treatment, the current status of oral lichen planus (location, size, severity of lesions, presence of pain and burning) and CFU count will be recorded. CFU sampling is performed using a sterile swab from the dorsal surface of the tongue. In general, CFU is expected to be positive in all patients, with values above 500 CFU/g.;Change in lesion severity based on Thongprasom criteria. Timepoint: Assessments will be conducted before treatment, and at weeks 1, 2, and 4. Method of measurement: The Thongprasom scale is used to assess the severity of oral lichen planus lesions as follows:0: No lesion, normal mucosa/1: Mild white lines without erythematous area/2: White lines with atrophic area less than 1 cm/3: White lines with atrophic area greater than 1 cm/4: White lines with ulcerative area less than 1 cm/5: White lines with ulcerative area greater than 1 cm.;Change in pain and burning sensation based on the Visual Analog Scale (VAS). Timepoint: Assessments will be conducted before treatment, and at weeks 1, 2, and 4. Method of measurement: The Visual Analog Scale (VAS) is a straight line, usually 100 millimeters long, printed on a sheet of paper. It has two defined endpoints: "No pain" on the left end and "Worst imaginable pain" on the right end. The patient marks their current pain level on this line using a pen. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of adverse effects related to nanocurcumin use. Timepoint: same as primary. Method of measurement: The patient will report any unusual symptoms or discomfort (such as nausea, diarrhea, headache, or skin reactions) to the investigator. These events will be recorded in standardized Adverse Event Forms. During each follow-up visit (weeks 1, 2, and 4), the physician will assess vital signs, general health, and any possible adverse reactions. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHelia Khosromanesh
Mashhad University of Medical Sciences
Outcome results
None listed