Photodynamic Therapy for Oral Precursor Lesions (PDT)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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.
Changes in percent (%) of the initial area in mm2 assessed on recall appointment and by a blinded examiner on photographs with a caliper. [ Time Frame: each treatment average once a week, recall after 4 weeks ]
Secondary Outcome Measures
pain due to treatment, assessed by visual analogue scale (VAS) [ Time Frame: each treatment, average once a week ]
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
Malignant changes of the mucous membrane, heavy Dysplasie SIN III, Carcinoma in situ - heavy vitamin deficiency
less than 18
No tobacco abuse
satisfying therapy with local immunmodulators in lichen ruber