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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biopsy with Er: YAG | Experimental | Removal of specimen biopsies in patients with leukoplakic or lichenoid mucosal lesions using Er: YAG laser under previous local anesthesia |
|
| Biopsy with Scalpel | Active Comparator | Biopsies taken with Er: YAG are compared with biopsies taken with a scalpel in patients with lichenoid or leukoplakic changes of the oral mucosa. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biopsy | Procedure | Removal of specimen biopsies in patients with leukoplakic or lichenoid mucosal lesions using Er: YAG laser or scalpel under previous local anesthesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 13 month |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative pain | The pain is measured by the visual analogue scale (VAS) 0-10, 0 = no pain, 10 = worst possible pain | 13 month |
| postoperative bleeding | The bleeding is determined with yes or no. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Barbara Giacomelli-Hiestand, Dr. | Contact | +41446343290 | barbara.giacomelli-hiestand@zz.uzh.ch |
| Name | Affiliation | Role |
|---|---|---|
| Martin Rücker, Prof.Dr.Dr. | Sponsor GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic for Oral Surgery, Center of dental medicine, University of Zurich | Zurich | 8032 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28120248 | Result | Suter VGA, Altermatt HJ, Bornstein MM. A randomized controlled clinical and histopathological trial comparing excisional biopsies of oral fibrous hyperplasias using CO2 and Er:YAG laser. Lasers Med Sci. 2017 Apr;32(3):573-581. doi: 10.1007/s10103-017-2151-8. Epub 2017 Jan 24. |
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| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| 13 month |
| time for removal | The time to remove is measured in seconds | 13 month |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |