Comparison of Sample Biopsy Using Scalpel or Er:YAG Laser

NCT03638973 | Unknown

• 1 other identifier: 2018-01364
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Laser Burn; Gingival Disease; Biopsy Wound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• postoperative pain

  13 month

• postoperative bleeding

  13 month

• time for removal

  13 month

Study Arms (2)

Biopsy with Er: YAG

EXPERIMENTAL

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

Procedure: Biopsy

Biopsy with Scalpel

ACTIVE COMPARATOR

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

Interventions

Biopsy PROCEDURE

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

Biopsy with Er: YAG; Biopsy with Scalpel

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication for biopsy of the oral mucosa
• male and female adult patients
• Written consent of the participating persons after clarification

You may not qualify if:

• pregnancy
• Taking blood thinners
• Known infectious diseases
• Untreated diabetes mellitus
• Taking immunosuppressants

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

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

Zurich, 8032, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 28120248 RESULT

MeSH Terms

Conditions

Gingival Diseases

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Martin Rücker, Prof.Dr.Dr.

  Sponsor GmbH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Giacomelli-Hiestand, Dr.

CONTACT

+41446343290; barbara.giacomelli-hiestand@zz.uzh.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 20, 2018
• Study Start: November 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2020
• Last Updated: October 12, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)