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

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

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.

Different treatments have been proposed for the management of oral leukoplakia (OL) in order to prevent oral squamous cell carcinoma onset. However, there is still no consensus on the most effective approach for the patients affected by such oral potentially malignant disorders. Surgery is often performed, but there is no randomized clinical trial which demonstrates its real effectiveness in preventing oral cancer onset. A recent RCT compared surgical treatment with "wait and see approach" care in patients with nondysplastic OL, assuming that regular clinical follow-up could be considered a reliable standard of care among patients with nondysplastic oral leukoplakias. The purpose of this study is to evaluate effectiveness of surgical excision in treating OL and or prolonging the onset of potential oral squamous cell carcinoma. This study will be the first RCT comparing the effectiveness of surgery to "wait and see approach" in the management of both dysplastic and nondysplastic oral leukoplakias.

The surgical removal of the lesion will follow these steps: local anesthesia excision of the lesion with surgical blade or laser, according to the clinical case, paying attention to having 5 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.

To evaluate the quality of life of patients affected by leukoplakia and treated with surgical excision, via Functional Intraoral Glasgow Scale (FIGS) questionnaire. FIGS is a simple point scale used to assess a patient's ability to speak, chew and swallow. Each of these functions is scored independently on a scale of 1-5, five being no disability and one meaning the patient has an inability to speak, chew, or swallow.

Inclusion Criteria: 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 Criteria: 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