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

Leukoplakia, Oral Clinical Trial

Official title:

Comparison Between Surgical Excision and "Wait and See" Approach in the Treatment of Oral Leukoplakia: a Randomized, Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04858100
• Other study ID #: LEUKO2020
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: March 1, 2026

Study information

• Verified date: March 2024
• Source: University of Milan
• Contact: Giovanni Lodi, PhD, DMD
• Phone: 00390250319021
• Email: giovanni.lodi[@]unimi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 approach for the patients affected by such oral potentially malignant disorders. Surgery is often performed, but there is no randomized clinical trial which demonstrates its real effectiveness in preventing oral cancer onset.

A recent RCT compared surgical treatment with "wait and see approach" care in patients with nondysplastic OL, assuming that regular clinical follow-up could be considered a reliable standard of care among patients with nondysplastic oral leukoplakias.

The purpose of this study is to evaluate effectiveness of surgical excision in treating OL and or reducing the onset of potential oral squamous cell carcinoma, with a follow-up of 5 years. This study will be the first RCT comparing the effectiveness of surgery to "wait and see approach" in the management of both dysplastic and nondysplastic oral leukoplakias.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukoplakia
• Leukoplakia, Oral

Intervention

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.

Locations

Country	Name	City	State
Italy	University of Milan	Milan
Italy	Università degli Studi di Torino Dental School	Turin	TO

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Time to malignant transformation from diagnosis	Period of time required to develop malignancy	every 3 or 6 months (according to clinical case) up to 5 years
Secondary	Quality of life after surgical excision	To evaluate the quality of life of patients affected by leukoplakia and treated with surgical excision, via Functional Intraoral Glasgow Scale (FIGS) questionnaire. FIGS is a simple point scale used to assess a patient's ability to speak, chew and swallow. Each of these functions is scored independently on a scale of 1-5, five being no disability and one meaning the patient has an inability to speak, chew, or swallow.	month 1 and month 6