Leukoplakia
Conditions
Interventions
This is a double-blind, randomized controlled clinical trial. Patients will be stratified by epidemiological characteristics and clinical features of the lesion. Block randomizations will be generated
(2) PVL treatment (complete removal of site-specific lesion) will be performed by applying a high-power diode laser, in surgical mode, (DMC U.S.A Plantation, FL, USA,), 940nm, 4 watts, pulsed mode, 10
(3) Treatment of OL will be performed by conventional surgical removal (n=30)
(4) Treatment of PVL will be performed by conventional site-specific surgical removal (n=30). Patients recruited and enrolled in the clinical study will be followed up on a quarterly basis for 24 mont
Sponsors
Universidade Estadual de Campinas
Universidade Estadual de Campinas
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: We will select 60 patients diagnosed with oral leukoplakia (OL) and 60 patients with proliferative verrucous leukoplakia (PVL) through biopsy and histological analysis. Only patients presenting with OL and PVL located in any region in the oral cavity will be selected. It is estimated that the participants will be mostly male smokers over 50 years of age for the diagnosis of OL and non-smoking women over 60 years of age for the diagnosis of PVL.
Exclusion criteria
Exclusion criteria: We will excluded patients with a history of previous oral carcinomas, chemotherapy, or radiation therapy in the head and neck region.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| We expect to find better healing and post-operative pain results in the laser arm when compared to the scalpel in the two-year follow-up period, using the Vancouver healing scale and the visual analog scale, respectively. | — |
Primary
| Measure | Time frame |
|---|---|
| It is hoped to find a reduction in the number of recurrences and malignant transformations in the laser arm compared to the scalpel arm over the two-year follow-up period, based on a variation of at least 5% in the pre- and post-intervention measurements. | — |
Countries
Brazil
Contacts
Public ContactCaique Pedroso
Universidade Estadual de Campinas
Outcome results
None listed