Leukoplakia Clinical Trial
— PDTOfficial title:
A Randomized Controlled Trial: Photodynamic Treatment for the Therapy of Premalignant Mucosal Oral Lesions.
Verified date | May 2017 |
Source | Medical University of Vienna |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | January 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Austria | Bernhard Gottlieb University Clinic of Dentistry | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in percent (%) of the initial area in mm2 assessed on recall appointment and by a blinded examiner on photographs with a caliper. | each treatment average once a week, recall after 4 weeks | ||
Secondary | pain due to treatment, assessed by visual analogue scale (VAS) | each treatment, average once a week |
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