Comparison of Sample Biopsy Using Scalpel or Er:YAG Laser

University of Zurich (UZH)

Status: Unknown

Conditions: Laser Burn; Gingival Disease; Biopsy Wound

Treatments: Procedure: Biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT03638973

2018-01364

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Biopsy with Er: YAG

Experimental group

Description:

Removal of specimen biopsies in patients with leukoplakic or lichenoid mucosal lesions using Er: YAG laser under previous local anesthesia

Treatment:

Procedure: Biopsy

Biopsy with Scalpel

Active Comparator group

Description:

Biopsies taken with Er: YAG are compared with biopsies taken with a scalpel in patients with lichenoid or leukoplakic changes of the oral mucosa.

Treatment:

Procedure: Biopsy