Oral Leukoplakia
Conditions
Interventions
Experimental Group:Pulsed Ablation Procedure
Control Group:Under the same operative environment and conditions, a simulated intervention was performed during the surgery.
Sponsors
West China Hospital of Stomatology, Sichuan University; School of Stomatology, Affiliated Hospital of Zhejiang University School of Medicine.
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18 to 70 years (inclusive). (2) Clinically and histopathologically diagnosed with oral leukoplakia, meeting one of the following criteria: a) With mild to moderate dysplasia. b) Without dysplasia, but the patient has a documented history of the lesion for at least 6 months at the time of screening, with poor response to conventional therapies. (3) The lesion is located in relatively flat areas such as the buccal mucosa or tongue and is clearly visible. (4) Able to understand the study objectives, willing to provide written informed consent, and able to comply with scheduled follow-up visits.
Exclusion criteria
Exclusion criteria: (1) Presence of severe epithelial dysplasia, carcinoma in situ, or invasive carcinoma on pathological biopsy. (2) Diffuse oral leukoplakia. (3) Use of immunosuppressive therapy within 1 month prior to enrollment (except for those who discontinued medication at least 1 month before screening). (4) Active infection or open wound in the proposed treatment area. (5) Presence of any active implantable medical device, such as a cardiac pacemaker, implantable cardioverter-defibrillator (ICD), cardiac resynchronization therapy (CRT) device, spinal cord stimulator, cochlear implant, or deep brain stimulator. (6) Severe coagulation dysfunction (platelet count 3 times the upper limit of normal (ULN), or international normalized ratio (INR) >= 1.5); or a history of active bleeding or significant bleeding tendency. (7) Known keloid formers. (8) Myocardial infarction, unstable angina, or severe cardiac insufficiency (e.g., NYHA Class III-IV) within the past 6 months. (9) Significant hepatic or renal impairment (ALT or AST > 1.5 times ULN; serum creatinine > 2.0 mg/dL or 177 µmol/L, or undergoing dialysis). (10) Life expectancy of less than 12 months. (11) Psychiatric disorders that would preclude cooperation with the treatment. (12) Other severe systemic diseases deemed by the investigator as unsuitable for the treatment. (13) Known dependency on drugs or alcohol, difficulty in understanding the trial protocol, or inability or unwillingness to comply with the scheduled follow-ups. (14) Pregnancy, lactation, or planning a pregnancy during the trial period. (15) Current or planned participation in another drug or medical device clinical trial (post-marketing registry studies excluded). (16) Any other condition considered by the investigator as inappropriate for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical efficacy rate at 3 months after the procedure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analog Scale for Pain;Oral Examination;Rate of Recurrence; | — |
Countries
China
Contacts
Public ContactLu Jiang
West China Hospital of Stomatology, Sichuan University
Outcome results
None listed