Clinical trial NCT03233165: Comparison Between Two Different High Power Ablative Lasers in the Treatment of Oral Leukoplakia
Official title: Comparison Between Two Different High Power Ablative Lasers in the Treatment of Oral Leukoplakia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leukoplakic Lesions
Keywords: laser therapy
recurrence
leukoplakia
precancerous lesion
Lead sponsor: University of Zagreb
Sponsor class: OTHER
First posted: 2017-07-28
Enrollment: 54
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* based clinically diagnosed non homogeneous leukoplakia

Exclusion Criteria:

* immunocompromised patients
* HIV positive patients
* patients on suppressive therapy

Primary outcomes:
measure: Recurrence rate
timeFrame: 6 months period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Zagreb
name: Dr. Dragana Gabrić
role: STUDY_DIRECTOR
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