<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03233165</url>
  </required_header>
  <id_info>
    <org_study_id>05-PA-26-6/2015</org_study_id>
    <nct_id>NCT03233165</nct_id>
  </id_info>
  <brief_title>Comparison Between Two Different High Power Ablative Lasers in the Treatment of Oral Leukoplakia</brief_title>
  <official_title>Comparison Between Two Different High Power Ablative Lasers in the Treatment of Oral Leukoplakia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zagreb</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zagreb</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Oral leukoplakia is a precancerous lesion with relatively high malignant transformation&#xD;
      potential. They are often treated by wide surgical excisions or conservative retinoids&#xD;
      therapy. The use of high power ablative lasers has been proposed as an effective way of&#xD;
      treating these lesions safely. The aim of this study was to evaluate efficiency Er:YAG and&#xD;
      Er,Cr:YSGG laser, in the treatment of oral leukoplakia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this research was to determine the effectiveness of two high-power ablative&#xD;
      lasers in the treatment of oral leukoplakia. Furthermore, the purpose was to compare&#xD;
      reciprocally and evaluate the subjective and objective postoperative parameters for two&#xD;
      different tested ablative lasers, Er: YAG and Er, Cr: YSGG.&#xD;
&#xD;
      All the patients were referred to the Department of Oral Medicine or Oral Surgery where a&#xD;
      biopsy and measuring the size of lesion that meet the criteria of the histopathological&#xD;
      diagnosis of leukoplakia was performed. Patients who met the conditions of pathohistological&#xD;
      diagnosis of leukoplakia and clinical criteria for diagnosis of non-homogeneous leukoplakia,&#xD;
      were included in the research.&#xD;
&#xD;
      The patients were randomly allocated into one of the two test groups. In the first group of&#xD;
      patients leukoplakia lesion were removed using high-power ablative laser Er: YAG and to those&#xD;
      in the second group using high power ablative Er, Cr: YSGG laser.&#xD;
&#xD;
      The patients were monitored one year and six months after treatment to evaluate subjective&#xD;
      and objective parameters focused on life quality after treatment and in case of eventual&#xD;
      relapse. Criteria of effectiveness for lasers were appearance of relaps in one year and six&#xD;
      months following.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 20, 2015</start_date>
  <completion_date type="Actual">March 20, 2017</completion_date>
  <primary_completion_date type="Actual">February 20, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recurrence rate</measure>
    <time_frame>6 months period</time_frame>
    <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.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Leukoplakic Lesions</condition>
  <arm_group>
    <arm_group_label>Patients with diagnosed leukoplakia 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who meet the conditions of pathohistological diagnosis of leukoplakia and clinical criteria for diagnosis of non-homogeneous leukoplakia.&#xD;
Intervention using Er:YAG laser</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with diagnosed leukoplakia 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who meet the conditions of pathohistological diagnosis of leukoplakia and clinical criteria for diagnosis of non-homogeneous leukoplakia.&#xD;
Intervention using Er,Cr:YSGG laser</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Er:YAG laser</intervention_name>
    <description>Ablation of the lesions Device: Er:YAG laser (LightWalker AT, Fotona, Slovenia, 2013) with a non-contact X-Runner digitally controled hand-piece.&#xD;
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.</description>
    <arm_group_label>Patients with diagnosed leukoplakia 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Er,Cr:YSGG laser</intervention_name>
    <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.</description>
    <arm_group_label>Patients with diagnosed leukoplakia 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  based clinically diagnosed non homogeneous leukoplakia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  immunocompromised patients&#xD;
&#xD;
          -  HIV positive patients&#xD;
&#xD;
          -  patients on suppressive therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr. Dragana Gabrić</last_name>
    <role>Study Director</role>
    <affiliation>University of Zagreb</affiliation>
  </overall_official>
  <reference>
    <citation>van der Waal I, Schepman KP, van der Meij EH, Smeele LE. Oral leukoplakia: a clinicopathological review. Oral Oncol. 1997 Sep;33(5):291-301. doi: 10.1016/s1368-8375(97)00002-x.</citation>
    <PMID>9415326</PMID>
  </reference>
  <reference>
    <citation>Nair DR, Pruthy R, Pawar U, Chaturvedi P. Oral cancer: Premalignant conditions and screening--an update. J Cancer Res Ther. 2012 Jan;8 Suppl 1:S57-66. doi: 10.4103/0973-1482.92217.</citation>
    <PMID>22322734</PMID>
  </reference>
  <reference>
    <citation>van der Waal I, Axell T. Oral leukoplakia: a proposal for uniform reporting. Oral Oncol. 2002 Sep;38(6):521-6. doi: 10.1016/s1368-8375(01)00125-7.</citation>
    <PMID>12167428</PMID>
  </reference>
  <reference>
    <citation>Holmstrup P, Dabelsteen E. Oral leukoplakia-to treat or not to treat. Oral Dis. 2016 Sep;22(6):494-7. doi: 10.1111/odi.12443. Epub 2016 Feb 11.</citation>
    <PMID>26785709</PMID>
  </reference>
  <reference>
    <citation>van der Waal I. Potentially malignant disorders of the oral and oropharyngeal mucosa; present concepts of management. Oral Oncol. 2010 Jun;46(6):423-5. doi: 10.1016/j.oraloncology.2010.02.016. Epub 2010 Mar 21.</citation>
    <PMID>20308005</PMID>
  </reference>
  <reference>
    <citation>Azma E, Safavi N. Diode laser application in soft tissue oral surgery. J Lasers Med Sci. 2013 Fall;4(4):206-11.</citation>
    <PMID>25606331</PMID>
  </reference>
  <reference>
    <citation>Silverman S Jr, Gorsky M, Lozada F. Oral leukoplakia and malignant transformation. A follow-up study of 257 patients. Cancer. 1984 Feb 1;53(3):563-8. doi: 10.1002/1097-0142(19840201)53:33.0.co;2-f.</citation>
    <PMID>6537892</PMID>
  </reference>
  <reference>
    <citation>Montebugnoli L, Frini F, Gissi DB, Gabusi A, Cervellati F, Foschini MP, Marchetti C. Histological and immunohistochemical evaluation of new epithelium after removal of oral leukoplakia with Nd:YAG laser treatment. Lasers Med Sci. 2012 Jan;27(1):205-10. doi: 10.1007/s10103-011-0941-y. Epub 2011 Jun 18.</citation>
    <PMID>21687980</PMID>
  </reference>
  <reference>
    <citation>Lodi G, Porter S. Management of potentially malignant disorders: evidence and critique. J Oral Pathol Med. 2008 Feb;37(2):63-9. doi: 10.1111/j.1600-0714.2007.00575.x.</citation>
    <PMID>18197849</PMID>
  </reference>
  <reference>
    <citation>Schoelch ML, Sekandari N, Regezi JA, Silverman S Jr. Laser management of oral leukoplakias: a follow-up study of 70 patients. Laryngoscope. 1999 Jun;109(6):949-53. doi: 10.1097/00005537-199906000-00021.</citation>
    <PMID>10369289</PMID>
  </reference>
  <reference>
    <citation>Chu FW, Silverman S Jr, Dedo HH. CO2 laser treatment of oral leukoplakia. Laryngoscope. 1988 Feb;98(2):125-30. doi: 10.1288/00005537-198802000-00001.</citation>
    <PMID>3123826</PMID>
  </reference>
  <reference>
    <citation>White JM, Chaudhry SI, Kudler JJ, Sekandari N, Schoelch ML, Silverman S Jr. Nd:YAG and CO2 laser therapy of oral mucosal lesions. J Clin Laser Med Surg. 1998 Dec;16(6):299-304. doi: 10.1089/clm.1998.16.299.</citation>
    <PMID>10204434</PMID>
  </reference>
  <reference>
    <citation>Roodenburg JL, Panders AK, Vermey A. Carbon dioxide laser surgery of oral leukoplakia. Oral Surg Oral Med Oral Pathol. 1991 Jun;71(6):670-4. doi: 10.1016/0030-4220(91)90271-d.</citation>
    <PMID>1905797</PMID>
  </reference>
  <reference>
    <citation>Rossmann JA, Brown RS, Hays GL, Lusk SS. Carbon dioxide laser surgical therapy for the management of oral leukoplakia: a case report. Tex Dent J. 1994 Dec;111(12):17-9, 21. No abstract available.</citation>
    <PMID>8633283</PMID>
  </reference>
  <reference>
    <citation>Ishii J, Fujita K, Komori T. Laser surgery as a treatment for oral leukoplakia. Oral Oncol. 2003 Dec;39(8):759-69. doi: 10.1016/s1368-8375(03)00043-5.</citation>
    <PMID>13679199</PMID>
  </reference>
  <reference>
    <citation>Meister J, Franzen R, Eyrich G, Bongartz J, Gutknecht N, Hering P. First clinical application of a liquid-core light guide connected to an Er:YAG laser for oral treatment of leukoplakia. Lasers Med Sci. 2010 Sep;25(5):669-73. doi: 10.1007/s10103-010-0782-0.</citation>
    <PMID>20393767</PMID>
  </reference>
  <reference>
    <citation>Schwarz F, Maraki D, Yalcinkaya S, Bieling K, Bocking A, Becker J. Cytologic and DNA-cytometric follow-up of oral leukoplakia after CO2- and Er:YAG-laser assisted ablation: a pilot study. Lasers Surg Med. 2005 Jul;37(1):29-36. doi: 10.1002/lsm.20188.</citation>
    <PMID>15954115</PMID>
  </reference>
  <reference>
    <citation>Seoane J, Gonzalez-Mosquera A, Lopez-Nino J, Garcia-Caballero L, Aliste C, Seoane-Romero JM, Varela-Centelles P. Er,Cr:YSGG laser therapy for oral leukoplakia minimizes thermal artifacts on surgical margins: a pilot study. Lasers Med Sci. 2013 Nov;28(6):1591-7. doi: 10.1007/s10103-013-1266-9. Epub 2013 Jan 17.</citation>
    <PMID>23324955</PMID>
  </reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 23, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>July 25, 2017</last_update_submitted>
  <last_update_submitted_qc>July 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Zagreb</investigator_affiliation>
    <investigator_full_name>Dragana Gabrić</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>laser therapy</keyword>
  <keyword>recurrence</keyword>
  <keyword>leukoplakia</keyword>
  <keyword>precancerous lesion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukoplakia</mesh_term>
    <mesh_term>Leukoplakia, Oral</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03233165
org study id: 05-PA-26-6/2015
nct id: NCT03233165
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Recurrence rate
time frame: 6 months period
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.
arm group label: Patients with diagnosed leukoplakia 1
arm group type: Experimental
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 group label: Patients with diagnosed leukoplakia 2
arm group type: Experimental
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: Er:YAG laser
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.
arm group label: Patients with diagnosed leukoplakia 1
intervention type: Procedure
intervention name: Er,Cr:YSGG laser
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.
arm group label: Patients with diagnosed leukoplakia 2
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Dr. Dragana Gabrić
role: Study Director
affiliation: University of Zagreb
citation: van der Waal I, Schepman KP, van der Meij EH, Smeele LE. Oral leukoplakia: a clinicopathological review. Oral Oncol. 1997 Sep;33(5):291-301. doi: 10.1016/s1368-8375(97)00002-x.
PMID: 9415326
citation: Nair DR, Pruthy R, Pawar U, Chaturvedi P. Oral cancer: Premalignant conditions and screening--an update. J Cancer Res Ther. 2012 Jan;8 Suppl 1:S57-66. doi: 10.4103/0973-1482.92217.
PMID: 22322734
citation: van der Waal I, Axell T. Oral leukoplakia: a proposal for uniform reporting. Oral Oncol. 2002 Sep;38(6):521-6. doi: 10.1016/s1368-8375(01)00125-7.
PMID: 12167428
citation: Holmstrup P, Dabelsteen E. Oral leukoplakia-to treat or not to treat. Oral Dis. 2016 Sep;22(6):494-7. doi: 10.1111/odi.12443. Epub 2016 Feb 11.
PMID: 26785709
citation: van der Waal I. Potentially malignant disorders of the oral and oropharyngeal mucosa; present concepts of management. Oral Oncol. 2010 Jun;46(6):423-5. doi: 10.1016/j.oraloncology.2010.02.016. Epub 2010 Mar 21.
PMID: 20308005
citation: Azma E, Safavi N. Diode laser application in soft tissue oral surgery. J Lasers Med Sci. 2013 Fall;4(4):206-11.
PMID: 25606331
citation: Silverman S Jr, Gorsky M, Lozada F. Oral leukoplakia and malignant transformation. A follow-up study of 257 patients. Cancer. 1984 Feb 1;53(3):563-8. doi: 10.1002/1097-0142(19840201)53:33.0.co;2-f.
PMID: 6537892
citation: Montebugnoli L, Frini F, Gissi DB, Gabusi A, Cervellati F, Foschini MP, Marchetti C. Histological and immunohistochemical evaluation of new epithelium after removal of oral leukoplakia with Nd:YAG laser treatment. Lasers Med Sci. 2012 Jan;27(1):205-10. doi: 10.1007/s10103-011-0941-y. Epub 2011 Jun 18.
PMID: 21687980
citation: Lodi G, Porter S. Management of potentially malignant disorders: evidence and critique. J Oral Pathol Med. 2008 Feb;37(2):63-9. doi: 10.1111/j.1600-0714.2007.00575.x.
PMID: 18197849
citation: Schoelch ML, Sekandari N, Regezi JA, Silverman S Jr. Laser management of oral leukoplakias: a follow-up study of 70 patients. Laryngoscope. 1999 Jun;109(6):949-53. doi: 10.1097/00005537-199906000-00021.
PMID: 10369289
citation: Chu FW, Silverman S Jr, Dedo HH. CO2 laser treatment of oral leukoplakia. Laryngoscope. 1988 Feb;98(2):125-30. doi: 10.1288/00005537-198802000-00001.
PMID: 3123826
citation: White JM, Chaudhry SI, Kudler JJ, Sekandari N, Schoelch ML, Silverman S Jr. Nd:YAG and CO2 laser therapy of oral mucosal lesions. J Clin Laser Med Surg. 1998 Dec;16(6):299-304. doi: 10.1089/clm.1998.16.299.
PMID: 10204434
citation: Roodenburg JL, Panders AK, Vermey A. Carbon dioxide laser surgery of oral leukoplakia. Oral Surg Oral Med Oral Pathol. 1991 Jun;71(6):670-4. doi: 10.1016/0030-4220(91)90271-d.
PMID: 1905797
citation: Rossmann JA, Brown RS, Hays GL, Lusk SS. Carbon dioxide laser surgical therapy for the management of oral leukoplakia: a case report. Tex Dent J. 1994 Dec;111(12):17-9, 21. No abstract available.
PMID: 8633283
citation: Ishii J, Fujita K, Komori T. Laser surgery as a treatment for oral leukoplakia. Oral Oncol. 2003 Dec;39(8):759-69. doi: 10.1016/s1368-8375(03)00043-5.
PMID: 13679199
citation: Meister J, Franzen R, Eyrich G, Bongartz J, Gutknecht N, Hering P. First clinical application of a liquid-core light guide connected to an Er:YAG laser for oral treatment of leukoplakia. Lasers Med Sci. 2010 Sep;25(5):669-73. doi: 10.1007/s10103-010-0782-0.
PMID: 20393767
citation: Schwarz F, Maraki D, Yalcinkaya S, Bieling K, Bocking A, Becker J. Cytologic and DNA-cytometric follow-up of oral leukoplakia after CO2- and Er:YAG-laser assisted ablation: a pilot study. Lasers Surg Med. 2005 Jul;37(1):29-36. doi: 10.1002/lsm.20188.
PMID: 15954115
citation: Seoane J, Gonzalez-Mosquera A, Lopez-Nino J, Garcia-Caballero L, Aliste C, Seoane-Romero JM, Varela-Centelles P. Er,Cr:YSGG laser therapy for oral leukoplakia minimizes thermal artifacts on surgical margins: a pilot study. Lasers Med Sci. 2013 Nov;28(6):1591-7. doi: 10.1007/s10103-013-1266-9. Epub 2013 Jan 17.
PMID: 23324955
responsible party type: Principal Investigator
investigator affiliation: University of Zagreb
investigator full name: Dragana Gabrić
investigator title: Clinical Professor
mesh term: Leukoplakia
mesh term: Leukoplakia, Oral
sharing ipd: Undecided