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

NCT ID: NCT06271564

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-29
• Study Completion Date: 2025-12-31

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 Nanoparticles.Magnetite 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 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:

Conditions

Oral Potentially Malignant Lesions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Magnetite Zno Composite Nanoparticles

5% topical ZnO-Fe3O4 Magnetic Composite NPs gel applied 3 times per day for 6 weeks

Group Type: EXPERIMENTAL

Magnetite ZnO Composite Nanoparticles

Intervention Type: DRUG

Magnetite 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

Topical Placebo Gel

Topical Placebo Gel containing water, glycerin and Hydroxypropyl methylcellulose applied 3 times per day for 6 weeks

Group Type: PLACEBO_COMPARATOR

Topical Placebo Gel

Intervention Type: DRUG

Topical placebo gel containing water, glycerin and Hydroxypropyl methylcellulose will be applied 3 times daily for 6 weeks as a positive control group

Interventions

Magnetite ZnO Composite Nanoparticles

Magnetite 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

Intervention Type: DRUG

Topical Placebo Gel

Topical placebo gel containing water, glycerin and Hydroxypropyl methylcellulose will be applied 3 times daily for 6 weeks as a positive control group

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Both genders ranged from 25 to 60 years.
• Clinically confirmed OPMLs: the clinical picture of oral erythroplakia includes well-demarcated red discs with a smooth or granular surface, leukoplakia is classified into four clinical types: type I, a flat white patch or plaque without red components; type II, a flat white patch or plaque with red components; type III, a slightly raised or elevated white plaque; and type IV, a markedly raised or elevated white plaque.
• Histopathological confirmed OPMLs with low or moderate dysplasia

Exclusion Criteria

• Presence of systemic conditions as serious active or recurrent infections, malignancy, diabetes mellitus, hypertension, or significant heart, liver, or renal diseases. Assessed using a medical questionnaire guided by Cornell Medical Index
• Smoking 6 weeks before the clinical trial
• Known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation as mentioned in history.
• Pregnancy or breastfeeding.
• Histological diagnosis of severe, or invasive oral squamous cell carcinoma.
• Vulnerable groups (Handicapped, orphans or prisoners).
• Any lesion less than 1 cm in diameter.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Nourhane Adel Abdel Halim Omara

Resident at Oral Medicine and Periodontology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ola Ezzatt, A.Professor

Role: STUDY_DIRECTOR

Faculty of Dentistry-Ain shams university

Locations

Faculty of Dentistry Ain shams University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Nourhane Omara, Master's

Role: CONTACT

nourhane.omara@hotmail.com

00201100794640

Hagar Mohamed Abd El Fatah, Lecturer

Role: CONTACT

Facility Contacts

Nourhane Omara, Master's

Role: primary

Other Identifiers

FDASU-Rec IM012415

Identifier Type: -

Identifier Source: org_study_id