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

May 30, 2014 updated by: Technical University of Munich

Clinical Trial Analyzing the Impact of Continuous Defocused CO2 Laser Vaporisation on the Histological Malignant Transformation of Erosive Oral Lichen Planus

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

263

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Symptomatic treatment
Symptomatic analgetic Treatment only was performed without any Manipulation of OLP lesions.
ACTIVE_COMPARATOR: CO2-Laser Treatment
CO2-Laser Vaporisation was performed of OLP lesions under local anaesthesia.
Device: CO2-Laser Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
stable disease of OLP (clinical observation)
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Development of oral cancer (histological report after incisional biopsy)
Time Frame: 3 years
3 years

Other Outcome Measures

Outcome Measure
Time Frame
Development of reccurrence of OLP (clinical observation)
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

March 27, 2014

First Submitted That Met QC Criteria

May 30, 2014

First Posted (ESTIMATE)

June 3, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

June 3, 2014

Last Update Submitted That Met QC Criteria

May 30, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TechnischeUM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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