Comparison Between Surgical Excision and Wait and See Approach in the Treatment of Oral Leukoplakia: a Randomized, Controlled Clinical Trial
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Italy
University of Milan
RECRUITING
Milan
Università degli Studi di Torino Dental School
RECRUITING
Turin
Contact Information
Primary
Giovanni Lodi, PhD, DMD
giovanni.lodi@unimi.it
00390250319021
Time Frame
Start Date: 2020-09-01
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 310
Treatments
Experimental: Surgery
Each patient will receive the surgical excision of the lesion and subsequent follow-up
Active_comparator: Wait and see
Each patient will receive clinical follow-up of the lesion with periodical incisional tissue biopsy.
Related Therapeutic Areas
Sponsors
Leads: University of Milan