Trials Sponsors Conditions Drugs Pricing

Conditions

Oral Potentially Malignant Lesions

Keywords

Oral Potentially Malignant LesionsOPLNanoparticlesZNO

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 NanoparticlesDrug

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 GelDrug

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

Eligibility Criteria

Age25 Years - 60 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

Ain Shams University
Otherlead

Study Sites (1)

Faculty of Dentistry Ain shams University

Cairo, Egypt

Study Officials

Ola Ezzatt, A.Professor
Faculty of Dentistry-Ain shams university
STUDY DIRECTOR

Enrollment

24 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, INVESTIGATOR, 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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Magnetite Zno Composite Nanoparticles

Topical Placebo Gel

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Magnetite Zno Composite Nanoparticles

Topical Placebo Gel

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations