Leukoplakia
Conditions
Interventions
Two randomization lists, in blocks of 5 patients, will be generated by a SAS program, version 8.02 and later distributed randomly in two arms:
(1) Treatment of oral leukoplakia (complete removal of th
(2). Treatment of oral leukoplakia will be performed through conventional surgical removal (30 patients).
Procedure/surgery
Sponsors
Faculdade de Odontologia de Piracicaba
Faculdade de Odontologia de Piracicaba
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients diagnosed with oral leukoplakia (through biopsy, performed and histologically analyzed at the Oral Pathology Service of the Piracicaba Dental School); epithelial dysplasia confirmed according to criteria established by the World Health Organization (WHO) by two experienced pathologists from the service; oral leukoplakia located in the region of the lateral border of the tongue, floor, retromolar region or soft palate
Exclusion criteria
Exclusion criteria: Will be excluded fron the study: patients with oral leukoplakia without epithelial dysplasia; with oral leukoplakia located in other regions that are not mentioned in the inclusion criteria; patients with a biopsy realized in other services than the Piracicaba dental School; with a history of previous oral carcinomas; chemotherapy or radiotherapy in the head and neck region
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the rates of recurrence and malignant transformation of oral leukoplakia with different treatment methods (scalpel and diode laser). These rates will be determined through careful clinical assessment of patients quarterly and biopsy when necessary. ;In addition, the proteomic profile of patients' saliva will also be evaluated to try to correlate clinical characteristics that may predict the greater chance of recurrence and / or malignant transformation.This evaluation will be carried out using the technique of proteomics by mass spectrometry. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of healing and postoperative pain of different methods of treatment of oral leukoplakia (scalpel and diode laser). Patients will be evaluated after the procedure (24 hours, 48 hours and 7 days) to classify pain on the visual analog scale and healing will be evaluated by a professional. | — |
Countries
Brazil
Contacts
Public ContactAlan dos Santos Silva
Faculdade de Odontologia de Piracicaba
Outcome results
None listed