Leukoplakia, Oral
Conditions
Keywords
Oral Potentially Malignant Disorder, Oral carcinoma, Oral medicine, Cancer prevention
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 cell carcinoma onset.
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 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.
Interventions
PROCEDURESurgical 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.
OTHERWait 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
University of Milan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oral cancer incidence | every 3 or 6 months (according to the clinical case) up to 5 years | Number of patients who will develop oral squamous cell carcinoma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to malignant transformation from diagnosis | every 3 or 6 months (according to clinical case) up to 5 years | Period of time required to develop malignancy |
| Quality of life after surgical excision | month 1 and month 6 | 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. |
Countries
Italy
Contacts
Primary ContactGiovanni Lodi, PhD, DMD
Outcome results
None listed