Using Magnetite Zinc Oxide Nanoparticles to Treat Oral Lesions
Effectiveness of Topical Magnetite Zinc Oxide Composite Nanoparticles in the Management of Oral Potentially Malignant Lesions (A Randomized Controlled Clinical Trial)
This study is testing a new gel made with special nanoparticles to see if it can help treat potentially cancerous oral lesions better than a placebo.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 25 Years to 60 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06271564 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a topical gel containing Magnetite Zinc Oxide-Fe3O4 Composite Nanoparticles in managing oral potentially malignant lesions (OPMLs). The study involves two groups: one receiving the active treatment and the other a placebo, with both groups monitored over an 18-week period. Patients will undergo clinical assessments and imaging to evaluate treatment efficacy at baseline, after 6 weeks of treatment, and at 18 weeks post-treatment. The trial aims to determine the selective cytotoxicity of the nanoparticles against cancerous cells while preserving healthy tissue.
Who should consider this trial
Good fit: Ideal candidates are adults aged 25 to 60 with clinically and histopathologically confirmed oral potentially malignant lesions exhibiting low or moderate dysplasia.
Not a fit: Patients with serious systemic conditions, recent smoking history, or known hypersensitivity to the treatment components may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel and effective option for managing oral potentially malignant lesions.
How similar studies have performed: While the use of nanoparticles in cancer treatment is a growing field, this specific approach with Magnetite Zinc Oxide-Fe3O4 Composite Nanoparticles is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cairo
- Faculty of Dentistry Ain shams University — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Nourhane Omara, Master's
- Email: nourhane.omara@hotmail.com
- Phone: 00201100794640
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.