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Comparison of Sample Biopsy Using Scalpel or Er:YAG Laser

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03638973
Recruitment Status : Unknown
Verified October 2018 by University of Zurich.
Recruitment status was:  Not yet recruiting
First Posted : August 20, 2018
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Study Description
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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.

Condition or disease Intervention/treatment Phase
Laser Burn Gingival Disease Biopsy Wound Procedure: Biopsy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Prospective Study for the Comparison of Sample Biopsy Using Scalpel or Er:YAG Laser
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Biopsy with Er: YAG
Removal of specimen biopsies in patients with leukoplakic or lichenoid mucosal lesions using Er: YAG laser under previous local anesthesia
 Procedure: Biopsy
Removal of specimen biopsies in patients with leukoplakic or lichenoid mucosal lesions using Er: YAG laser or scalpel under previous local anesthesia.
Active Comparator: Biopsy with Scalpel
Biopsies taken with Er: YAG are compared with biopsies taken with a scalpel in patients with lichenoid or leukoplakic changes of the oral mucosa.
 Procedure: Biopsy
Removal of specimen biopsies in patients with leukoplakic or lichenoid mucosal lesions using Er: YAG laser or scalpel under previous local anesthesia.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. postoperative pain [ Time Frame: 13 month ]
    The pain is measured by the visual analogue scale (VAS) 0-10, 0 = no pain, 10 = worst possible pain

  2. postoperative bleeding [ Time Frame: 13 month ]
    The bleeding is determined with yes or no.

  3. time for removal [ Time Frame: 13 month ]
    The time to remove is measured in seconds


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03638973


Contacts
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Contact: Barbara Giacomelli-Hiestand, Dr. +41446343290 barbara.giacomelli-hiestand@zz.uzh.ch

Locations
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Switzerland
Clinic for Oral Surgery, Center of dental medicine, University of Zurich
Zürich, Switzerland, 8032
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Martin Rücker, Prof.Dr.Dr. Sponsor GmbH
More Information
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Publications of Results:

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03638973    
Other Study ID Numbers: 2018-01364
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases