Oral Potentially Malignant Disorders: Comparison Between Surgical Treatment and Wait and See Approach
- Conditions
- Leukoplakia, Oral
- Interventions
- Procedure: Surgical excision of the lesionOther: Wait and see approach
- Registration Number
- NCT04858100
- Lead Sponsor
- University of Milan
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 310
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Surgery Surgical excision of the lesion Each patient will receive the surgical excision of the lesion and subsequent follow-up Wait and see Wait and see approach Each patient will receive clinical follow-up of the lesion with periodical incisional tissue biopsy.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (2)
Università degli Studi di Torino Dental School
🇮🇹Turin, TO, Italy
University of Milan
🇮🇹Milan, Italy