Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06271564
Status:
RECRUITING
Last Update Posted:
2024-03-05
First Post:
2024-02-12
Brief Title:
Effectiveness of Topical Magnetite Zinc Oxide Composite Nanoparticles in the Management of Oral Potentially Malignant Lesions
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Effectiveness of Topical Magnetite Zinc Oxide Composite Nanoparticles in the Management of Oral Potentially Malignant Lesions A Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
ZnO nanoparticles are now being widely researched for their anticancer properties They show relatively high biocompatibility They also show selective cytotoxicity against cancerous cells in in vitro condition compared with other nanoparticles They can be further surface engineered to show increased selective cytotoxicity The synthesis process of ZnO nanoparticles is relatively easy with a wide variety of methods Owing to these different methods of synthesis their size and size distribution can be easily controlled One of the novel methods of synthesis of ZnO is Magnetite ZnO-Fe3O4 Composite NanoparticlesMagnetite ZnO-Fe3O4 conjugated NPs retained inherent selective property of ZnO and magnetic property of Fe3O4 NPs and showed preferential cytotoxicity towards breast cancer cell line MDA-MB-231 with no significant cytotoxicity towards noncancerous Mouse Fibroblast NIH 3T3 cell
Detailed Description:
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 mucosaGroup 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 periodIV-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
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 periodIV-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None