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
About this trial
This is an interventional treatment trial for Leukoplakic Lesions focused on measuring laser therapy, recurrence, leukoplakia, precancerous lesion
Eligibility Criteria
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
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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Comparison Between Two Different High Power Ablative Lasers in the Treatment of Oral Leukoplakia
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