Comparison of Sample Biopsy Using Scalpel or Er:YAG Laser

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Prospective Study for the Comparison of Sample Biopsy Using Scalpel or Er:YAG Laser

Conditions
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Laser Burn, Gingival Disease, Biopsy Wound

Intervention / Treatment
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* Procedure: Biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biopsy with Er: YAG<br>Removal of specimen biopsies in patients with leukoplakic or lichenoid mucosal lesions using Er: YAG laser under previous local anesthesia | Procedure: Biopsy<br>* Removal of specimen biopsies in patients with leukoplakic or lichenoid mucosal lesions using Er: YAG laser or scalpel under previous local anesthesia.<br>|
| Active Comparator: Biopsy with Scalpel<br>Biopsies taken with Er: YAG are compared with biopsies taken with a scalpel in patients with lichenoid or leukoplakic changes of the oral mucosa. | Procedure: Biopsy<br>* Removal of specimen biopsies in patients with leukoplakic or lichenoid mucosal lesions using Er: YAG laser or scalpel under previous local anesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 13 month | 
| time for removal | The time to remove is measured in seconds | 13 month |