Oral leukoplakia
Conditions
Interventions
Study 2: Group Unresponsive to Photodynamic Therapy:None
Study 1: Photodynamic Therapy Group:None
Study 2: Group Responding to Photodynamic Therapy:None
Study 1: Photodynamic Therapy Combined with Retinoic Acid Group:None
Sponsors
Beijing Stomatological Hospital , Capital Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for Study 1: Photodynamic therapy group and photodynamic therapy combined with retinoic acid group: (1) Individuals aged between 18 and 85 years, irrespective of gender; (2) Histopathologically confirmed diagnosis of oral leukoplakia. Inclusion Criteria for Study 2: 1. Photodynamic Therapy (PDT) Group (Effective Treatment Subgroup): (1) Individuals aged between 18 and 85 years, irrespective of gender; (2) Histopathologically confirmed diagnosis of oral leukoplakia; (3) Lesions with a maximum diameter exceeding 3 cm; (4) Demonstrated effective response to photodynamic therapy, encompassing both complete and partial remission; (5) Signed informed consent for participation in the biobank. 2. Photodynamic Therapy (PDT) Non-responsive Group: (1) Individuals aged between 18 and 85 years, regardless of gender; (2) Histopathologically confirmed diagnosis of oral leukoplakia; (3) Extensive oral leukoplakia characterized by lesions with a diameter greater than 3 cm; (4) Lack of response to photodynamic therapy, with the lesion remaining stable upon assessment; (5) Signed informed consent for participation in the biobank.
Exclusion criteria
Exclusion criteria: Exclusion Criteria for Study 1: 1. Photodynamic Therapy Group: (1) Known allergy to photosensitizers (topical aminepentanoic acid hydrochloride powder) or porphyrins; (2) Pregnant or breastfeeding women; (3) Patients with psychiatric disorders, those lacking behavioral control, or those unable to ensure completion of treatment. 2. Photodynamic Therapy Combined with Retinoic Acid Group: (1) Known allergy to photosensitizers (topical aminepentanoic acid hydrochloride powder) or porphyrins; (2) Pregnant or lactating women; (3) Patients with severe hepatic or renal impairment (ALT and AST levels exceeding five times the upper limit of normal) and abnormally elevated blood lipids (total cholesterol >= 6.22 mmol/L, triglycerides >= 2.3 mmol/L) who cannot tolerate oral retinoic acid therapy; (4) Patients planning to become pregnant within one year of treatment; (5) Patients with psychiatric disorders, those lacking behavioral control, or those unable to ensure completion of treatment. Exclusion criteria for Study 2: None.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differential gene expression between PDT responders and non-responders;Clinical response after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in oral leukoplakia lesion area;Degree of epithelial dysplasia;Exfoliative cytology indicators; | — |
Countries
China
Contacts
Public ContactYao Liu
Beijing Stomatological Hospital, Capital Medical University
Outcome results
None listed