Effectiveness of Topical Magnetite Zinc Oxide Composite Nanoparticles in the Management of Oral Potentially Malignant Lesions

Two interventions will be used; Magnetite ZnO-Fe3O4 Composite NPs extract and Placebo gel in custom made inert hydrophilic adhesive gel paste will be prepared in Nanotechnology engineering service in Egypt (Nano Gate), to enhance the adhesiveness of the two study interventions to oral mucosa.Group I (Test Group): Will include 15 patients with OPLs that will be treated with 5% topical ZnO-Fe3O4 Magnetic Composite NPs gel applied 3 times per day33 for 6 weeks9. Group II (Positive Control Group): Will include 15 patients with oral lichen planus lesions that will be treated with Topical Placebo Gel applied 3 times per day for 6 weeks. The whole study period will be 18 weeks; 6 weeks as an active treatment period starting 1 week after the biopsy is taken then treatment discontinued for all groups and patients will be followed up for another 12 weeks in a treatment-free period.IV-Treatment efficacy evaluation A) Clinical efficacy assessment The assessment will be carried out at 0, 6 weeks and 18 weeks after starting the treatment protocol. 1-Imaging of the oral marker lesion Standardized photographs of the oral marker lesion for each patient will be taken with the same digital camera and setting, the surface area of the lesion will be outlined and measured using specific image software. Histopathological analysis B- The biopsy specimens for each patient will be taken at baseline and after 6 weeks of the treatment period and at 18 weeks for follow up then formalin-fixed and paraffin-embedded for: