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Comparison of Sample Biopsy Using Scalpel or Er:YAG Laser

Primary Purpose

Laser Burn, Gingival Disease, Biopsy Wound

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Biopsy
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laser Burn

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Clinic for Oral Surgery, Center of dental medicine, University of Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Biopsy with Er: YAG

Biopsy with Scalpel

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

postoperative pain
The pain is measured by the visual analogue scale (VAS) 0-10, 0 = no pain, 10 = worst possible pain
postoperative bleeding
The bleeding is determined with yes or no.
time for removal
The time to remove is measured in seconds

Full Information

First Posted
August 13, 2018
Last Updated
October 11, 2018
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT03638973
Brief Title
Comparison of Sample Biopsy Using Scalpel or Er:YAG Laser
Official Title
Randomized Prospective Study for the Comparison of Sample Biopsy Using Scalpel or Er:YAG Laser
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Anticipated)
Primary Completion Date
November 1, 2019 (Anticipated)
Study Completion Date
November 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laser Burn, Gingival Disease, Biopsy Wound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biopsy with Er: YAG
Arm Type
Experimental
Arm Description
Removal of specimen biopsies in patients with leukoplakic or lichenoid mucosal lesions using Er: YAG laser under previous local anesthesia
Arm Title
Biopsy with Scalpel
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Biopsy
Intervention Description
Removal of specimen biopsies in patients with leukoplakic or lichenoid mucosal lesions using Er: YAG laser or scalpel under previous local anesthesia.
Primary Outcome Measure Information:
Title
histological assessability
Description
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
Time Frame
13 month
Secondary Outcome Measure Information:
Title
postoperative pain
Description
The pain is measured by the visual analogue scale (VAS) 0-10, 0 = no pain, 10 = worst possible pain
Time Frame
13 month
Title
postoperative bleeding
Description
The bleeding is determined with yes or no.
Time Frame
13 month
Title
time for removal
Description
The time to remove is measured in seconds
Time Frame
13 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara Giacomelli-Hiestand, Dr.
Phone
+41446343290
Email
barbara.giacomelli-hiestand@zz.uzh.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Rücker, Prof.Dr.Dr.
Organizational Affiliation
Sponsor GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic for Oral Surgery, Center of dental medicine, University of Zurich
City
Zürich
ZIP/Postal Code
8032
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28120248
Citation
Suter VGA, Altermatt HJ, Bornstein MM. A randomized controlled clinical and histopathological trial comparing excisional biopsies of oral fibrous hyperplasias using CO2 and Er:YAG laser. Lasers Med Sci. 2017 Apr;32(3):573-581. doi: 10.1007/s10103-017-2151-8. Epub 2017 Jan 24.
Results Reference
result

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Comparison of Sample Biopsy Using Scalpel or Er:YAG Laser

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