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

NCT04858100 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2024-03-07

No results posted yet for this study

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.

Conditions

  • Leukoplakia, Oral

Interventions

PROCEDURE

Surgical excision of the lesion

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.

OTHER

Wait and see approach

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.

Sponsors & Collaborators

  • University of Milan

    lead OTHER

Principal Investigators

  • Giovanni Lodi, PhD, DMD · University of Milan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2026-03-01
Completion
2026-03-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04858100 on ClinicalTrials.gov