Oral Potentially Malignant Disorders: Comparison Between Surgical Treatment and Wait and See Approach
Comparison Between Surgical Excision and "Wait and See" Approach in the Treatment of Oral Leukoplakia: a Randomized, Controlled Clinical Trial
University of Milan
310 participants
Sep 1, 2020
INTERVENTIONAL
Conditions
Summary
This research protocol is comparing the effectiveness of surgical excision to the "wait and see" approach for the management of oral leukoplakia and erythroleukoplakia in prevention of oral squamous cell carcinoma onset.
Eligibility
Inclusion Criteria5
- OL diagnosis should be confirmed by incisional diagnostic biopsy and subsequent histopathological analysis
- Subjects' age: 18 years or older
- Lesions' size: 3 cm maximum longitudinal size of the single lesion
- Lesions's location: oral areas with no surgical risk of damages to important anatomical structures such as nerves, salivary ducts and/or arteries.
- Ability to understand and to sign a written informed consent document
Exclusion Criteria5
- Previous oral cancer
- Head and neck radiotherapy
- Subjects under the age of 18
- Subjects affected by PVL (proliferative verrucous leukoplakia)
- High-risk of surgical damages to anatomical structures such as nerves, salivary ducts and/or arteries
Interventions
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.
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.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04858100