Randomized Prospective Study for the Comparison of Sample Biopsy Using Scalpel or Er:YAG Laser
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Laser Burn
- Sponsor
- University of Zurich
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- histological assessability
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
histological assessability
Time Frame: 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 Outcomes
- postoperative pain(13 month)
- postoperative bleeding(13 month)
- time for removal(13 month)