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Comparison Between Two Different High Power Ablative Lasers in the Treatment of Oral Leukoplakia

Primary Purpose

Leukoplakic Lesions

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Er:YAG laser
Er,Cr:YSGG laser
Sponsored by
University of Zagreb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukoplakic Lesions focused on measuring laser therapy, recurrence, leukoplakia, precancerous lesion

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • based clinically diagnosed non homogeneous leukoplakia

Exclusion Criteria:

  • immunocompromised patients
  • HIV positive patients
  • patients on suppressive therapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Patients with diagnosed leukoplakia 1

    Patients with diagnosed leukoplakia 2

    Arm Description

    Patients who meet the conditions of pathohistological diagnosis of leukoplakia and clinical criteria for diagnosis of non-homogeneous leukoplakia. Intervention using Er:YAG laser

    Patients who meet the conditions of pathohistological diagnosis of leukoplakia and clinical criteria for diagnosis of non-homogeneous leukoplakia. Intervention using Er,Cr:YSGG laser

    Outcomes

    Primary Outcome Measures

    Recurrence rate
    At a recall visit after six months there were no recurrence of all leukoplakia which were ablated by use of Er:YAG and Er;Cr:YSGG laser.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 23, 2017
    Last Updated
    July 25, 2017
    Sponsor
    University of Zagreb
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03233165
    Brief Title
    Comparison Between Two Different High Power Ablative Lasers in the Treatment of Oral Leukoplakia
    Official Title
    Comparison Between Two Different High Power Ablative Lasers in the Treatment of Oral Leukoplakia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 20, 2015 (Actual)
    Primary Completion Date
    February 20, 2017 (Actual)
    Study Completion Date
    March 20, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Zagreb

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Oral leukoplakia is a precancerous lesion with relatively high malignant transformation potential. They are often treated by wide surgical excisions or conservative retinoids therapy. The use of high power ablative lasers has been proposed as an effective way of treating these lesions safely. The aim of this study was to evaluate efficiency Er:YAG and Er,Cr:YSGG laser, in the treatment of oral leukoplakia.
    Detailed Description
    The purpose of this research was to determine the effectiveness of two high-power ablative lasers in the treatment of oral leukoplakia. Furthermore, the purpose was to compare reciprocally and evaluate the subjective and objective postoperative parameters for two different tested ablative lasers, Er: YAG and Er, Cr: YSGG. All the patients were referred to the Department of Oral Medicine or Oral Surgery where a biopsy and measuring the size of lesion that meet the criteria of the histopathological diagnosis of leukoplakia was performed. Patients who met the conditions of pathohistological diagnosis of leukoplakia and clinical criteria for diagnosis of non-homogeneous leukoplakia, were included in the research. The patients were randomly allocated into one of the two test groups. In the first group of patients leukoplakia lesion were removed using high-power ablative laser Er: YAG and to those in the second group using high power ablative Er, Cr: YSGG laser. The patients were monitored one year and six months after treatment to evaluate subjective and objective parameters focused on life quality after treatment and in case of eventual relapse. Criteria of effectiveness for lasers were appearance of relaps in one year and six months following.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Leukoplakic Lesions
    Keywords
    laser therapy, recurrence, leukoplakia, precancerous lesion

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Patients with diagnosed leukoplakia 1
    Arm Type
    Experimental
    Arm Description
    Patients who meet the conditions of pathohistological diagnosis of leukoplakia and clinical criteria for diagnosis of non-homogeneous leukoplakia. Intervention using Er:YAG laser
    Arm Title
    Patients with diagnosed leukoplakia 2
    Arm Type
    Experimental
    Arm Description
    Patients who meet the conditions of pathohistological diagnosis of leukoplakia and clinical criteria for diagnosis of non-homogeneous leukoplakia. Intervention using Er,Cr:YSGG laser
    Intervention Type
    Procedure
    Intervention Name(s)
    Er:YAG laser
    Intervention Description
    Ablation of the lesions Device: Er:YAG laser (LightWalker AT, Fotona, Slovenia, 2013) with a non-contact X-Runner digitally controled hand-piece. Settings for the Er:YAG laser were as follows: pulse mode was Quantum Square Pulse (QSP), pulse energy of 120mJ, frequency of 20Hz and water sprey level was set to10ml per minute.
    Intervention Type
    Procedure
    Intervention Name(s)
    Er,Cr:YSGG laser
    Intervention Description
    Ablation of the lesions Device: Er,Cr:YSGG laser(WaterLase iPlus, Biolase LTD, USA) using contact mode. Settings were subsequent: power 50W, frequency 50Hz and concentration ratio of air and water was 2:4.
    Primary Outcome Measure Information:
    Title
    Recurrence rate
    Description
    At a recall visit after six months there were no recurrence of all leukoplakia which were ablated by use of Er:YAG and Er;Cr:YSGG laser.
    Time Frame
    6 months period

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: based clinically diagnosed non homogeneous leukoplakia Exclusion Criteria: immunocompromised patients HIV positive patients patients on suppressive therapy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dr. Dragana Gabrić
    Organizational Affiliation
    University of Zagreb
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
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    Citation
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    Comparison Between Two Different High Power Ablative Lasers in the Treatment of Oral Leukoplakia

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