Comparison Between Surgical Excision and "Wait and See" Approach in the Treatment of Oral Leukoplakia: a Randomized, Controlled Clinical Trial
Sponsor study identifier
interventional
310
1 country
2
Study Start
September 1, 2020
Actual (reported)Primary Completion
March 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2020
Actual (reported)March 2, 2021
Actual (reported)April 26, 2021
Actual (reported)March 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Oral cancer incidence
Number of patients who will develop oral squamous cell carcinoma
every 3 or 6 months (according to the clinical case) up to 5 years
Time to malignant transformation from diagnosis
every 3 or 6 months (according to clinical case) up to 5 years
Quality of life after surgical excision
month 1 and month 6
Each patient will receive the surgical excision of the lesion and subsequent follow-up
Each patient will receive clinical follow-up of the lesion with periodical incisional tissue biopsy.
The surgical removal of the lesion, performed within 3 months from the final diagnosis, will follow these steps: * local anesthesia * excision of the lesion with surgical blade or laser, according to the clinical case, paying attention to having at least 2 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.
Università degli Studi di Torino Dental School
Turin, TO, 10126, Italy
University of Milan
Milan, 20142, Italy
Giovanni Lodi, PhD, DMD
University of Milan
First Submitted
March 2, 2021
First Posted
April 26, 2021
Study Start
September 1, 2020
Actual (reported)Primary Completion
March 1, 2026
Estimated (date passed)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. In case of OSCC onset during the first 3 months after the final diagnosis, the patient will be excluded since the oral cancer occurence will be considered as a misdiagnosis, more than a "true" malignat progression.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 7, 2024
Record last verified: 2024-03
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Source: ClinicalTrials.gov.
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