| Registry | NCT03233165 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 54 (Actual) |
| Sponsor | University of Zagreb (Other) |
| Conditions | Leukoplakic Lesions |
| Interventions | Er:YAG laser, Er,Cr:YSGG laser (Procedure) |
| Dates | start 2015-02-20, primary completion 2017-02-20, completion 2017-03-20, first posted 2017-07-28, last updated 2017-07-28 |
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Leukoplakic Lesions All trials of Er:YAG laser All trials of Er,Cr:YSGG laser
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Patients with diagnosed leukoplakia 1 | Experimental | Procedure: Er:YAG laser | Patients who meet the conditions of pathohistological diagnosis of leukoplakia and clinical criteria for diagnosis of non-homogeneous leukoplakia. Intervention using Er:YAG laser |
| Patients with diagnosed leukoplakia 2 | Experimental | Procedure: Er,Cr:YSGG laser | 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 |
Sex: All
Inclusion Criteria: * based clinically diagnosed non homogeneous leukoplakia Exclusion Criteria: * immunocompromised patients * HIV positive patients * patients on suppressive therapy