Photodynamic therapy in oral lichen planus: A prospective case-controlled pilot study
Phase 3
- Conditions
- Oral Lichen PlanusTherapy
- Registration Number
- DRKS00017540
- Lead Sponsor
- niversitätsklinikum Gießen und Marburg, Standort Marburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Inclusion criteria were: minimal age 18, histologically proven OLP with clinical symptoms: pain, burning sensation, impaired eating, written consent to participate in the study.
Exclusion Criteria
Exclusion criteria were patients that did not fulfill the inclusion criteria as well as presence of pregnancy, renal insufficiency, HIV-, Hepatitis C and untreated heart disease.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome: lesion size<br>Lesions were measured and scored at baseline (prior to first PDT) and 2, 4 and 6 weeks after the last PDT session. Lesion size was measured horizontally and vertically at the nearest 0.5 mm with a periodontal probe (PCP UNC-15, Hu-Friedy) and with an image measuring software (ImageJ2) using clinical photographs. Lesions were scored using the Thongprasom score. Treatment evaluation were scored 2, 4, 6 weeks after PDT as proposed by Carozzo and Gandolfo.
- Secondary Outcome Measures
Name Time Method Before therapy and 6 weeks after therapy clinical (lesion size), and immunological (from blood, and tissue biopsy) parameters will be evaluated.<br>Peripheral blood and lesional T-cells are analysed before and after PDT treatment as follows:<br>Peripheral mononuclear cells will be determined from blood and tissue biopsies; T-lymphocytes will be analysed by using Cytometry, and their subgroups using Elispot methods. The plasma will also be analysed for potentiel T-cell induced auto-antibody reaction (for the described antigens) and for determining the immune or T-cell modulated proteins. Both parameters will be determined using Enzyme-linked Immunoabsorbant Assay (ELIZA). <br>Patient centered outcomes including burning sensations, pain, pain during eating or performane of oral hygiene care will also be assed before and after therapy.