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

RECRUITINGN/ASponsored by University of Milan
Actively Recruiting
PhaseN/A
SponsorUniversity of Milan
Started2020-09-01
Est. completion2026-03-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT04858100

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

CancerLeukoplakia, Oral

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