Biopsy Wound, Gingival Disease, Laser Burn
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREBiopsy
Removal of specimen biopsies in patients with leukoplakic or lichenoid mucosal lesions using Er: YAG laser or scalpel under previous local anesthesia.
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Indication for biopsy of the oral mucosa * male and female adult patients * Written consent of the participating persons after clarification
Exclusion criteria
* pregnancy * Taking blood thinners * Known infectious diseases * Untreated diabetes mellitus * Taking immunosuppressants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| histological assessability | 13 month | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative pain | 13 month | The pain is measured by the visual analogue scale (VAS) 0-10, 0 = no pain, 10 = worst possible pain |
| postoperative bleeding | 13 month | The bleeding is determined with yes or no. |
| time for removal | 13 month | The time to remove is measured in seconds |
Countries
Switzerland
Contacts
Primary ContactBarbara Giacomelli-Hiestand, Dr.
Outcome results
None listed