Photodynamic therapy in oral lichen planus: A prospective case-controlled pilot study

Photodynamic therapy in oral lichen planus: A prospective case-controlled pilot study - OLP

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00017540

Enrollment

Registered

2019-07-01

Start date

2014-09-18

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Lichen Planus Therapy

Interventions

Group 1: Patients suffering of oral lichen planus will be treated with photodynamic therapy: The lesions will be treated in 4 sessions within 2 weeks. This is a painless therapy that does not require

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

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: 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.

Design outcomes

Primary

Measure	Time frame
Primary outcome: lesion size 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.	—

Measure

Time frame

Primary outcome: lesion size 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.

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Secondary

Measure	Time frame
Before therapy and 6 weeks after therapy clinical (lesion size), and immunological (from blood, and tissue biopsy) parameters will be evaluated. Peripheral blood and lesional T-cells are analysed before and after PDT treatment as follows: 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). Patient centered outcomes including burning sensations, pain, pain during eating or performane of oral hygiene care will also be assed before and after therapy.	—

Measure

Time frame

Before therapy and 6 weeks after therapy clinical (lesion size), and immunological (from blood, and tissue biopsy) parameters will be evaluated. Peripheral blood and lesional T-cells are analysed before and after PDT treatment as follows: 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). Patient centered outcomes including burning sensations, pain, pain during eating or performane of oral hygiene care will also be assed before and after therapy.

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Countries

Germany

Contacts

Public ContactRaluca Cosgarea

Universitätsklinikum Gießen und Marburg GmbH, Standort Marburg Zentrum für Zahn-, Mund- und Kieferheilkunde Abteilung für Parodontologie

ralucacosgarea@gmail.com06421 - 58 63235

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026