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RecruitingNot ApplicableNCT04858100

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

Sponsor

University of Milan

Enrollment

310 participants

Start Date

Sep 1, 2020

Study Type

INTERVENTIONAL

Conditions

Leukoplakia, Oral

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two approaches for managing oral leukoplakia — a white patch in the mouth that can sometimes turn into cancer — either surgically removing it or closely monitoring it without immediate treatment ("wait and see"). **You may be eligible if...** - You have been diagnosed with oral leukoplakia confirmed by a biopsy - You are 18 years or older - Your lesion is no larger than 3 cm - The lesion is in an area of the mouth where surgery can be done safely **You may NOT be eligible if...** - You have previously had oral cancer - Your lesion is near important nerves, salivary ducts, or arteries that could be damaged by surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESurgical 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.

OTHERWait 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.

Locations(2)

University of Milan

Milan, Italy

Università degli Studi di Torino Dental School

Turin, TO, Italy

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NCT04858100