Photodynamic Therapy for Oral Precursor Lesions

Medical University of Vienna28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Leukoplakia Lichen

Interventions

Aminolaevulinic acidOTHER

Photodynamic therapy

Methylcellulose PlaceboOTHER

Methylcellulose

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Bernhard Gottlieb University Clinic of Dentistry

Vienna, Austria

Outcomes

Primary Outcomes

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 Outcomes

pain due to treatment, assessed by visual analogue scale (VAS)

Time frame: each treatment, average once a week

Data from ClinicalTrials.gov

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