Status:
RECRUITING
Oral Potentially Malignant Disorders: Comparison Between Surgical Treatment and Wait and See Approach
Lead Sponsor:
University of Milan
Conditions:
Leukoplakia, Oral
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 c...
Detailed Description
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT04858100
Start Date
September 1 2020
End Date
March 1 2026
Last Update
March 7 2024
Active Locations (2)
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1
Università degli Studi di Torino Dental School
Turin, TO, Italy, 10126
2
University of Milan
Milan, Italy, 20142