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

NCT06271564 | Recruiting Early Phase 1 DMC

• 1 other identifier: FDASU-Rec IM012415
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Potentially Malignant Lesions

Keywords

Oral Potentially Malignant Lesions; OPL; Nanoparticles; ZNO

Outcome Measures

Primary Outcomes (1)

• Change in the clinical size in Low to Moderate Dysplastic OPLs using Magnetite ZnO-Fe3O4 Composite NPs using standardized photographs of the oral marker lesion for each patient

  the surface area of the lesion will be outlined and measured using specific image software.

  6 weeks

Secondary Outcomes (1)

• Effect of Magnetite ZnO-Fe3O4 Composite NPs on the change of the degree of Dysplasia during histopathological examination using a biopsy

  6 weeks

Study Arms (2)

Magnetite Zno Composite Nanoparticles

EXPERIMENTAL

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

Drug: Magnetite ZnO Composite Nanoparticles

Topical Placebo Gel

PLACEBO COMPARATOR

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

Drug: Topical Placebo Gel

Interventions

Magnetite ZnO Composite Nanoparticles 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

Magnetite Zno Composite Nanoparticles

Topical Placebo Gel DRUG

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

Topical Placebo Gel

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry Ain shams University

Cairo, Egypt

RECRUITING

Study Officials

• Ola Ezzatt, A.Professor

  Faculty of Dentistry-Ain shams university

  STUDY DIRECTOR

Central Study Contacts

Nourhane Omara, Master's

CONTACT

00201100794640; nourhane.omara@hotmail.com

Hagar Mohamed Abd El Fatah, Lecturer

CONTACT

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Oral Medicine and Periodontology Department

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 22, 2024
• Study Start: February 29, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

EG (1)