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Leukoplakic LesionsNCT03233165

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

A study testing Er:YAG laser and Er,Cr:YSGG laser in people with Leukoplakic Lesions, run by University of Zagreb.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Leukoplakic Lesions
What is being tested?
Er:YAG laser and Er,Cr:YSGG laser
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
No sites listed yet
Study dates
20 Feb 2015to 20 Mar 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • based clinically diagnosed non homogeneous leukoplakia

Who cannot join

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

About this study

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.

Read the 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.

Being tested
Er:YAG laser, Er,Cr:YSGG laser
Keywords
laser therapy, recurrence, leukoplakia, precancerous lesion
Medical subject headings
Leukoplakia, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Er:YAG laserProcedure or surgery

    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 laserProcedure or surgery

    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.

Study groups in NCT03233165
Study groupRoleWhat they receive
Patients with diagnosed leukoplakia 1ExperimentalPatients who meet the conditions of pathohistological diagnosis of leukoplakia and clinical criteria for diagnosis of non-homogeneous leukoplakia. Intervention using Er:YAG laser
Receives: Procedure: Er:YAG laser
Patients with diagnosed leukoplakia 2ExperimentalPatients who meet the conditions of pathohistological diagnosis of leukoplakia and clinical criteria for diagnosis of non-homogeneous leukoplakia. Intervention using Er,Cr:YSGG laser
Receives: Procedure: Er,Cr:YSGG laser

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2017
  2. Study start20 Feb 2015
  3. Primary completion20 Feb 2017
  4. Study completion20 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03233165
Sponsor's protocol ID
05-PA-26-6/2015
Status last verified
Jul 2017
First submitted
23 Jul 2017
Last updated
28 Jul 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 9415326

  • 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.

    PubMed 22322734

  • 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.

    PubMed 12167428

  • 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.

    PubMed 26785709

  • 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.

    PubMed 20308005

  • Azma E, Safavi N. Diode laser application in soft tissue oral surgery. J Lasers Med Sci. 2013 Fall;4(4):206-11.

    PubMed 25606331

  • 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.

    PubMed 6537892

  • 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.

    PubMed 21687980

  • 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.

    PubMed 18197849

  • 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.

    PubMed 10369289

  • 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.

    PubMed 3123826

  • 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.

    PubMed 10204434

  • 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.

    PubMed 1905797

  • 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.

    PubMed 8633283

  • 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.

    PubMed 13679199

Questions about this trial

What is this clinical trial studying?

A study testing Er:YAG laser and Er,Cr:YSGG laser in people with Leukoplakic Lesions, run by University of Zagreb.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence rate (time frame: 6 months period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03233165, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2017.

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