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

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ClinicalTrials.gov Identifier: NCT03233165
Recruitment Status : Completed
First Posted : July 28, 2017
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
Dragana Gabrić, University of Zagreb

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.

Condition or disease Intervention/treatment Phase
Leukoplakic Lesions Procedure: Er:YAG laser Procedure: Er,Cr:YSGG laser Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Two Different High Power Ablative Lasers in the Treatment of Oral Leukoplakia
Actual Study Start Date : February 20, 2015
Actual Primary Completion Date : February 20, 2017
Actual Study Completion Date : March 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients with diagnosed leukoplakia 1

Patients who meet the conditions of pathohistological diagnosis of leukoplakia and clinical criteria for diagnosis of non-homogeneous leukoplakia.

Intervention using Er:YAG laser

Procedure: Er:YAG laser

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.


Experimental: Patients with diagnosed leukoplakia 2

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

Procedure: Er,Cr:YSGG laser
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 Measures :
  1. Recurrence rate [ Time Frame: 6 months period ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • based clinically diagnosed non homogeneous leukoplakia

Exclusion Criteria:

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

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): NCT03233165


Sponsors and Collaborators
University of Zagreb
Investigators
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Study Director: Dr. Dragana Gabrić University of Zagreb

Publications:

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Responsible Party: Dragana Gabrić, Clinical Professor, University of Zagreb
ClinicalTrials.gov Identifier: NCT03233165     History of Changes
Other Study ID Numbers: 05-PA-26-6/2015
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dragana Gabrić, University of Zagreb:
laser therapy
recurrence
leukoplakia
precancerous lesion
Additional relevant MeSH terms:
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Leukoplakia
Leukoplakia, Oral
Precancerous Conditions
Neoplasms
Pathological Conditions, Anatomical
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases