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

  • End date
    Mar 1, 2026
  • participants needed
  • sponsor
    University of Milan
Updated on 8 May 2021


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.

Condition oral leukoplakia
Treatment Surgical excision of the lesion, Wait and see approach
Clinical Study IdentifierNCT04858100
SponsorUniversity of Milan
Last Modified on8 May 2021


Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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