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
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
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
NCT ID
NCT02154607
First Posted
March 27, 2014
Last Updated
May 30, 2014
Sponsor
Technical University of Munich
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
Impact of Continuous Defocused CO2 Laser Vaporisation on the Histological Malignant Transformation of Erosive Oral Lichen Planus in Patients
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