Oral Potentially Malignant Disorders: Comparison Between Surgical Treatment and Wait and See Approach

NARecruitingINTERVENTIONAL
Enrollment

310

Participants

Timeline

Start Date

September 1, 2020

Primary Completion Date

March 1, 2026

Study Completion Date

March 1, 2026

Conditions
Leukoplakia, Oral
Interventions
PROCEDURE

Surgical excision of the lesion

"The surgical removal of the lesion, performed within 3 months from the final diagnosis, will follow these steps:~* local anesthesia~* excision of the lesion with surgical blade or laser, according to the clinical case, paying attention to having at least 2 mm-free margins~* silk or resorbable suture for wound closure~The patient will be recall after 14 days for assessing the wound healing and after 30 days for providing and explaining him the histopahtological exam.~The patient will receive a 3-6 month follow-up according to the clinical and histopathological case."

OTHER

Wait and see approach

"The patient will receive a 3-6 month follow-up according to the clinical and histopathological case, with periodical incisional biopsy every 4 control visit.~In case of OSCC onset during the first 3 months after the final diagnosis, the patient will be excluded since the oral cancer occurence will be considered as a misdiagnosis, more than a true malignat progression."

Trial Locations (2)

10126

RECRUITING

Università degli Studi di Torino Dental School, Turin

20142

RECRUITING

University of Milan, Milan

All Listed Sponsors
lead

University of Milan

OTHER