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

Oral Lichen Planus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02154607
• Other study ID #: TechnischeUM
• Status: Completed
• Phase: N/A
• First received: March 27, 2014
• Last updated: May 30, 2014
• Start date: January 2004
• Est. completion date: December 2013

Study information

• Verified date: May 2014
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: December 2013
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Lichen Planus
• Lichen Planus, Oral
• Oral Lichen Planus

Intervention

Device:
• CO2-Laser Treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Development of reccurrence of OLP (clinical observation)		3 years	No
Primary	stable disease of OLP (clinical observation)		1 year	Yes
Secondary	Development of oral cancer (histological report after incisional biopsy)		3 years	Yes