Health Condition 1: K132- Leukoplakia and other disturbancesof oral epithelium, including tongue
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: a) Clinical diagnosis of Oral Leukoplakia (Homogenous and non-homogenous); b) Gender: All eligible for study c) Lesion size: 2 cm maximum longitudinal size of the single lesion. d) Lesions’ location: Oral areas with no surgical risk of damages to important anatomical structures such as nerves, salivary ducts and/or arteries. e) Histopathological diagnosis of epithelial dysplasia on incisional biopsy.
Exclusion criteria
Exclusion criteria: a) Presence of histological signs of oral lichen planus, on the basis of WHO criteria, b) Presence of clinical and histological signs of proliferative verrucous leukoplakia, on the basis of the 2010 and 2013 classifications; c) Presence of white lesions on the lip vermillion; d) Incapacity to understand verbal and written instructions; e) Pregnant or breast-feeding women; f) Previous or current diagnosis of oral squamous cell carcinoma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oral cancer development in the same place of the primary disease as confirmed by histopathological examination.Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Safety of the intervention, as measured by the incidence of severe adverse effects 2) Clinical fading (in GROUP I: incidence of recurrences or new lesion; in GROUP II: clinical worsening of the primary lesions or recurrence of new lesions).Timepoint: 6 months | — |
Countries
India
Contacts
Dental College, RIMS, Ranchi