Comparison of Sample Biopsy Using Scalpel or Er:YAG Laser

Sponsor

University of Zurich (Other)

Overall Status

Unknown status

CT.gov ID

NCT03638973

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Laser Burn Gingival Disease Biopsy Wound	Procedure: Biopsy	N/A

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

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Nov 1, 2018

Anticipated Primary Completion Date :

Nov 1, 2019

Anticipated Study Completion Date :

Nov 1, 2020

Arms and Interventions

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.

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

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Clinic for Oral Surgery, Center of dental medicine, University of Zurich	Zürich		Switzerland	8032

Sponsors and Collaborators

University of Zurich

Investigators

Principal Investigator: Martin Rücker, Prof.Dr.Dr., Sponsor GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Zurich

ClinicalTrials.gov Identifier:

NCT03638973

Other Study ID Numbers:

2018-01364

First Posted:

Aug 20, 2018

Last Update Posted:

Oct 12, 2018

Last Verified:

Oct 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Gingival Diseases

Study Results

No Results Posted as of Oct 12, 2018