Photodynamic Therapy for Oral Precursor Lesions (PDT)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
Pre-malignant lesions are difficult to treat. Even after surgical removal they tend to re-appear. Often the lesions are to large and are apparent on many sites, therefore surgical removal is not always possible. The photodynamic therapy uses a special substance, which is absorbed in cells, and thereafter activated by a defined light. The aim of this study is to compare the photodynamic therapy in potentially malignant lesions to a placebo. The investigators assume a significant better result in photodynamic therapy then treatment with a placebo.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Existing Leukoplakia simplex SIN III (diagnostics by Biopsie)
- Leukoplakia verrucosa without indications of malignant changes (diagnostics by Biopsie)
- Oral Lichen planus SIN III (diagnostics by Biopsie)
- Good mouth hygiene status (tartar, surface)
- Correct seat of the prosthesis and/or the denture
- Located erosions in the oral cavity
- Minimum age:18 years
- Women at the age capable of child-bearing with an appropriate contraception
Exclusion criteria
- Malignant changes of the mucous membrane, heavy Dysplasie SIN III, Carcinoma in situ - heavy vitamin deficiency
- Pregnancy
- less than 18
- Satisfying women
- No tobacco abuse
- satisfying therapy with local immunmodulators in lichen ruber
- surgical therapy of leukoplakia indicated
Trial design
Primary purpose
Allocation
Interventional model
Masking
28 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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