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

NCT03233165 | Completed DMC

• 1 other identifier: 05-PA-26-6/2015
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Leukoplakic Lesions

Keywords

laser therapy; recurrence; leukoplakia; precancerous lesion

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Patients with diagnosed leukoplakia 1

EXPERIMENTAL

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

Patients with diagnosed leukoplakia 2

EXPERIMENTAL

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

Interventions

Er:YAG laser PROCEDURE

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 1

Er,Cr:YSGG laser PROCEDURE

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.

Patients with diagnosed leukoplakia 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• based clinically diagnosed non homogeneous leukoplakia

You may not qualify if:

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

Sponsors & Collaborators

• University of Zagreb: lead

Related Publications (18)

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• 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.

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MeSH Terms

Conditions

Leukoplakia; Recurrence

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Dr. Dragana Gabrić

  University of Zagreb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 23, 2017
• First Posted: July 28, 2017
• Study Start: February 20, 2015
• Primary Completion: February 20, 2017
• Study Completion: March 20, 2017
• Last Updated: July 28, 2017

Record last verified: 2017-07