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

NCT ID: NCT02154607

Last Updated: 2014-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

263 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2013-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Oral Lichen Planus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Symptomatic treatment

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

Group Type NO_INTERVENTION

No interventions assigned to this group

CO2-Laser Treatment

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

Group Type ACTIVE_COMPARATOR

CO2-Laser Treatment

Intervention Type DEVICE

Interventions

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CO2-Laser Treatment

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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TechnischeUM

Identifier Type: -

Identifier Source: org_study_id

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