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

Leukoplakic Lesions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03233165
• Other study ID #: 05-PA-26-6/2015
• Status: Completed
• Phase: N/A
• First received: July 23, 2017
• Last updated: July 25, 2017
• Start date: February 20, 2015
• Est. completion date: March 20, 2017

Study information

• Verified date: July 2017
• Source: University of Zagreb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 20, 2017
• Est. primary completion date: February 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• based clinically diagnosed non homogeneous leukoplakia

Exclusion Criteria:

• immunocompromised patients

• HIV positive patients

• patients on suppressive therapy

Related Conditions & MeSH terms

• Leukoplakia
• Leukoplakia, Oral
• Leukoplakic Lesions

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Zagreb

References & Publications (18)

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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. — View 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. — View Citation

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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. — View Citation

Schwarz F, Maraki D, Yalcinkaya S, Bieling K, Böcking 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. — View Citation

Seoane J, González-Mosquera A, López-Niño J, García-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. — View 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. — View Citation

van der Waal I, Axéll T. Oral leukoplakia: a proposal for uniform reporting. Oral Oncol. 2002 Sep;38(6):521-6. Review. — View 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. Review. — View 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. Review. — View 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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months period