Oral leukoplakia
Conditions
Interventions
One year supplement of 5mg 2 times/day of beta-carotene and 250mg 2 times/day of vitamin C
One year supplement of 25mg 2 times/day of vitamin C
Sponsors
Department of Maxillofacial Surgery, Aichi-Gakuin University School of Dentistry
Department of Oral Medicine, WHO Collaborating Centre for Oral Cancer Precancer,King'
s College Dental Institute at Guy'
s,King'
s&
St.Thomas'
Hospitals London,UK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Predominantly white lesion of oral mucosa clinically diagnosed as leukoplakia based on the WHO criteria and confirmed histologically 2) Both non-dysplastic and those with mild to moderate dysplasia histo-pathologically 3) Non-smokers or ex-smokers more than 3 months 4) Discontinuing to take any over the counter micronutrient supplements 4 weeks prior to entering the trial
Exclusion criteria
Exclusion criteria: 1) Any other specific disorders that could appear as a white lesion such as frictional keratosis, hairly leukoplakia, leukoedema, oral lichen planus and erythroplakia 2) Severe dysplasia, carcinoma in situ or micro-invasive carcinoma 3) Current smokers 4) Having adverse medical problems 5) Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical remission | — |
Secondary
| Measure | Time frame |
|---|---|
| Likelihood of malignant transformation | — |
Countries
Japan
Contacts
Public ContactHideo Fukano
Chemoprevention Study Group for Oral Leukoplakia Department of Maxillofacial Surgery, Aichi-Gakuin University School of Dentistry
Outcome results
None listed