Health Condition 1: D103- Benign neoplasm of other and unspecified parts of mouth
Conditions
Interventions
Intervention1: 2.5 percent Toludine Blue mediated Photodynamic therapy ( wavelength ranging from 630-660nm(Fluence 15 J/cm2) as light source) once a week for 4 weeks along with preventive and conventi
Sponsors
All India Institute of Medical Sciences N Delhi
Eligibility
Inclusion criteria
Inclusion criteria: All newly diagnosed cases of Oral Leukoplakia with size more or equal to 2 cm2 (Van der Waal classification more or equal to L2) Subjects clinically and histologically diagnosed as Oral Leukoplakia. Subjects more or equal to 18 years of age. Subjects willing to participate in the study and to complete the treatment sessions.
Exclusion criteria
Exclusion criteria: History of any topical and/or systemic therapy for Oral Leukoplakia other than general management in last 2 months. Subjects with current or past history of malignancy. Subjects with any lesion suspicious of malignancy requiring biopsy. Subjects with severe dysplasia and carcinoma in situ on biopsy of oral lesion Subjects with history of hyperphotosensitivity (genetic disorders, dermatological conditions, drug induced, systemic conditions) Subjects with calcium, Vit D metabolic and parathyroid disorders Pregnant and lactating females.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response (Chen et al 2021) 1) complete remission of the lesion clinically evaluated; Complete Response CR 2) partial reduction of at least 20% in the total diameter of the lesion; Partial response PR 3) reduction of the lesion by less than 20% in diameter; No Response NR Timepoint: 4 weeks from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response (Chen et al 2021) 1) complete remission of the lesion clinically evaluated; Complete Response CR 2) partial reduction of at least 20% in the total diameter of the lesion; Partial response PR 3) reduction of the lesion by less than 20% in diameter; No Response NR Timepoint: at 12 weeks from baseline;Lesion sizeTimepoint: At 4 weeks and 12 weeks from baseline;Lesion roughness/ whiteness ( Femanio et al)Timepoint: At 4 weeks and 12 weeks from baseline;Oral Health quality of life (OHIP-14)Timepoint: At 4 weeks and 12 weeks from baseline;Adverse eventsTimepoint: at any time from baseline;RecurrenceTimepoint: At any time from baseline | — |
Countries
India
Contacts
Public ContactDr Jatin Lonyal
All India Institute of Medical Sciences N Delhi
Outcome results
None listed