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Impact of Continuous Defocused CO2 Laser Vaporisation on the Histological Malignant Transformation of Erosive Oral Lichen Planus in Patients

Primary Purpose

Oral Lichen Planus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CO2-Laser Treatment
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oral Lichen Planus focused on measuring oral lichen planus, recurrence, Treatment, cancer, Primary disease Management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Oral lichen planus
  • Histological confirmation of diagnosis
  • Patient willing for treatment

Exclusion Criteria:

  • Patient just does not want to participate as control/study group

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    Symptomatic treatment

    CO2-Laser Treatment

    Arm Description

    Symptomatic analgetic Treatment only was performed without any Manipulation of OLP lesions.

    CO2-Laser Vaporisation was performed of OLP lesions under local anaesthesia.

    Outcomes

    Primary Outcome Measures

    stable disease of OLP (clinical observation)

    Secondary Outcome Measures

    Development of oral cancer (histological report after incisional biopsy)

    Full Information

    First Posted
    March 27, 2014
    Last Updated
    May 30, 2014
    Sponsor
    Technical University of Munich
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02154607
    Brief Title
    Impact of Continuous Defocused CO2 Laser Vaporisation on the Histological Malignant Transformation of Erosive Oral Lichen Planus in Patients
    Official Title
    Clinical Trial Analyzing the Impact of Continuous Defocused CO2 Laser Vaporisation on the Histological Malignant Transformation of Erosive Oral Lichen Planus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2004 (undefined)
    Primary Completion Date
    November 2011 (Actual)
    Study Completion Date
    December 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Technical University of Munich

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Oral Lichen Planus (OLP) is a common condition with its erosive variant occasionally presenting a management challenge to the clinician. In addition it can have debilitating consequences on the patients' quality of life. The malignant transformation of OLP has been well documented. The aims of this work were to measure the number of patients developing malignant transformationof OLP to squamous cell carcinoma (SCC) comparing patients undergoing traditional symptomatic treatments with those patients that were treated by CO2 laser from 2004 - 2011. Outcome measures were rated by incisional biopsy (histology Report).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oral Lichen Planus
    Keywords
    oral lichen planus, recurrence, Treatment, cancer, Primary disease Management

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    263 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Symptomatic treatment
    Arm Type
    No Intervention
    Arm Description
    Symptomatic analgetic Treatment only was performed without any Manipulation of OLP lesions.
    Arm Title
    CO2-Laser Treatment
    Arm Type
    Active Comparator
    Arm Description
    CO2-Laser Vaporisation was performed of OLP lesions under local anaesthesia.
    Intervention Type
    Device
    Intervention Name(s)
    CO2-Laser Treatment
    Primary Outcome Measure Information:
    Title
    stable disease of OLP (clinical observation)
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Development of oral cancer (histological report after incisional biopsy)
    Time Frame
    3 years
    Other Pre-specified Outcome Measures:
    Title
    Development of reccurrence of OLP (clinical observation)
    Time Frame
    3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Oral lichen planus Histological confirmation of diagnosis Patient willing for treatment Exclusion Criteria: Patient just does not want to participate as control/study group

    12. IPD Sharing Statement

    Learn more about this trial

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