For certain changes in the oral mucosa a histopathological examination of the affected tissue is indicated to confirm the diagnosis. The gold standard is the biopsy by scalpel. The aim of this study is to compare the alternative method of tissue sampling using the erbium doped yttrium aluminium garnet (Er:YAG) laser with the gold Standard.
Various parameters are compared, such as the pain intensity during and after the biopsy, the evaluation of the tissue removed by the histopathologist, the occurrence of bleeding during and after the removal and the time required for both therapies. Patients who agree to participate in the study will be randomized (randomly) to either therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Removal of specimen biopsies in patients with leukoplakic or lichenoid mucosal lesions using Er: YAG laser or scalpel under previous local anesthesia.
Clinic for Oral Surgery, Center of dental medicine, University of Zurich
Zurich, Switzerland
histological assessability
The primary endpoint is the histological assessability of the samples. This is evaluated by the histologist and divided into degrees 0-3. The Subdivision of the artifacts takes place according to the following degrees: 0: none, 1: slight artifacts, not affecting the evaluation of the sample, 2: moderate artifacts, slight deterioration in the evaluability of the sample, 3: severe artifacts, severely impaired
Time frame: 13 month
postoperative pain
The pain is measured by the visual analogue scale (VAS) 0-10, 0 = no pain, 10 = worst possible pain
Time frame: 13 month
postoperative bleeding
The bleeding is determined with yes or no.
Time frame: 13 month
time for removal
The time to remove is measured in seconds
Time frame: 13 month
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