Comparison Between Two Different High Power Ablative Lasers in the Treatment of Oral Leukoplakia
NCT ID: NCT03233165
Last Updated: 2017-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
54 participants
INTERVENTIONAL
2015-02-20
2017-03-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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.
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
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* HIV positive patients
* patients on suppressive therapy
ALL
No
Sponsors
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University of Zagreb
OTHER
Responsible Party
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Dragana Gabrić
Clinical Professor
Principal Investigators
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Dr. Dragana Gabrić
Role: STUDY_DIRECTOR
University of Zagreb
References
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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.
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.
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.
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.
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.
Azma E, Safavi N. Diode laser application in soft tissue oral surgery. J Lasers Med Sci. 2013 Fall;4(4):206-11.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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05-PA-26-6/2015
Identifier Type: -
Identifier Source: org_study_id
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