Comparison of Sample Biopsy Using Scalpel or Er:YAG Laser

Biopsy Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03638973
• Other study ID #: 2018-01364
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: November 1, 2020

Study information

• Verified date: October 2018
• Source: University of Zurich
• Contact: Barbara Giacomelli-Hiestand, Dr.
• Phone: +41446343290
• Email: barbara.giacomelli-hiestand[@]zz.uzh.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: November 1, 2020
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Biopsy Wound
• Gingival Disease
• Gingival Diseases
• Laser Burn
• Periodontal Diseases

Intervention

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

Locations

Country	Name	City	State
Switzerland	Clinic for Oral Surgery, Center of dental medicine, University of Zurich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Suter VG, Altermatt HJ, Bornstein MM. A randomized controlled clinical and histopathological trial comparing excisional biopsies of oral fibrous hyperplasias using CO(2) and Er:YAG laser. Lasers Med Sci. 2017 Apr;32(3):573-581. doi: 10.1007/s10103-017-215 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	postoperative pain	The pain is measured by the visual analogue scale (VAS) 0-10, 0 = no pain, 10 = worst possible pain	13 month
Secondary	postoperative bleeding	The bleeding is determined with yes or no.	13 month
Secondary	time for removal	The time to remove is measured in seconds	13 month