Comparison of Sample Biopsy Using Scalpel or Er:YAG Laser

Not Applicable

• Conditions: Laser Burn; Biopsy Wound; Gingival Disease
• Interventions: Procedure: Biopsy

• Registration Number: NCT03638973
• Lead Sponsor: University of Zurich

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.

Study Timeline

• Study First Submitted: 2018-08-13
• Study First Submitted QC: 2018-08-17
• Study First Posted: 2018-08-20
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-11
• Last Update Posted: 2018-10-12
• Study Start: 2018-11-01
• Primary Completion: 2019-11-01
• Study Completion: 2020-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biopsy with Er: YAG	Biopsy	Removal of specimen biopsies in patients with leukoplakic or lichenoid mucosal lesions using Er: YAG laser under previous local anesthesia
Biopsy with Scalpel	Biopsy	Biopsies taken with Er: YAG are compared with biopsies taken with a scalpel in patients with lichenoid or leukoplakic changes of the oral mucosa.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Clinic for Oral Surgery, Center of dental medicine, University of Zurich; 🇨🇭 Zürich, Switzerland