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Efficacy and safety evaluation of laser pretreatment combined with 5-aminolevulinic acid-mediated photodynamic therapy for oral mucosal leukoplakia

Efficacy and safety evaluation of laser pretreatment combined with 5-aminolevulinic acid-mediated photodynamic therapy for oral mucosal leukoplakia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106062
Enrollment
Unknown
Registered
2025-07-16
Start date
2025-07-16
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral leukoplakia

Interventions

Experimental Group:Laser pretreatment

Sponsors

Peking University School of Stomatology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1 Age: 18-75 years old, gender not limited, Han Chinese. 2 Meet the diagnostic criteria for oral leukoplakia (OLK) : 3 Lesions that occur on the oral mucosa and are mainly white cannot be wiped off, nor can they be clinically or histologically observed Pathological methods diagnose it as other definable lesions, which fall within the category of precancerous lesions or potential malignant disorders This does not include oral leukokeratosis that can subside after the removal of factors such as smoking and local friction. 4 To ensure the consistency of treatment, the maximum diameter of the lesion should not exceed 4cm. Only homogeneous leukoplakia and verrucous leukoplakia were included Spots and granular white patches.

Exclusion criteria

Exclusion criteria: 1 Pregnant women, lactating women, and women of childbearing age with pregnancy plans within one year. 2 Accompanied by other oral mucosal disorders 3 Accompanied by severe acute infectious diseases throughout the body; Uncontrolled systemic diseases (coagulation disorders, autoimmune diseases, diabetes, cardiovascular diseases, mental illnesses, etc. Suffering from malignancy in other parts of the body. 4 Those who have received surgical treatment or radiotherapy and chemotherapy for potential malignant oral diseases or head and neck tumors in the past patient. 5 People who are allergic to light within a wavelength range of approximately 630±5nm. 6 Those who are allergic to any component in the topical solution of aminovaleric hydrochloride. 7 People who are allergic to local anesthetic drugs. 8 People allergic to porphyrins. 9 Any patient who is unwilling or unable to receive this treatment for any other reason.

Design outcomes

Primary

MeasureTime frame
Clinical effectiveness;Treatment time per unit area of lesion;VAS ;Course of treatment;

Secondary

MeasureTime frame
Toluidine blue staining;Autofluorescence examination;DNA polyploid examination of exfoliated cells;

Countries

China

Contacts

Public ContactYing Han

Peking University School of Stomatology

13683375487@163.com+86 136 8337 5487

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026