Dual-light Antibacterial Photodynamic Therapy as an Adjunctive Treatment to Corticosteroid Treatment in OLP

Oral Lichen Planus (OLP) is a relatively common, chronic immune-mediated mucocutaneous disease,that usually occurs on the oral mucosa surfaces. Oral lesions are commonly multiple with a bilateral and symmetrical localization. Most affected sites in the oral cavity are the buccal and lingual mucosa, and the gingiva. Approximately 10% of patients with OLP present manifestations in the gingiva.

Lumoral is a CE-marked medical device developed to provide a potent, targeted antibacterial action on dental plaque in a home environment. The device mechanism of action is antibacterial photodynamic therapy (aPDT). The device is used by swishing a mouth rinse, which has a strong adherence to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple to use light applicator. Use of the device can improve supragingival plaque control. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction.

A total of 60 subjects with histologically confirmed diagnosis of OLP with gingival involvement are enrolled to the study. The subjects are randomized to a study group and a control group. Both groups will use topical corticosteroid treatment for two weeks. In addition, the study group will use Lumoral-device initially once a day.

All the subjects shall be assessed for desquamative gingivitis clinical score (DGCS), Escudier Index (EI), visible plaque index (VPI), bleeding on probing index (BOP), pain score (VAS), aMMP-8 inflammation marker and oral candidosis. These analyses shall be performed at baseline and at 4 week, 3, 6 and 12 months after the treatment started.

In addition, psychosocial factors shall be assessed by the graded chronic pain scale (GCPS), the oral health impact profile (OHIP-14) and the generalized anxiety disorder (GAD-7) questionnaires at baseline and at 6 and 12 months after the treatment initiation.

Primary outcome is improvement in average Pain score (VAS) symptom diary during the 12 month study period.

• Lumoral treatment (Device), also known as Lumorinse mouth rinse: The investigational Lumoral treatment -device provides a constant and repeatable application which can be done at home and is easily available. All subjects in the study group will receive their own Lumoral treatment -device and Lumorinse-mouth rinse tablets for the complete duration of the study.
• Standard oral hygiene self care (Other), also known as Sonic toothbrush provided: Both groups shall be given oral and written instructions for twice-daily standard oral hygiene self care.

Primary outcomes

• Pain score symptom diary (based on Visual Analogue Scale - VAS) [12 months]: Improvement in average Pain score (VAS) symptom diary during the 12 month study period. Assessments: 1. '365 Average pain score' (VAS) is determined by calculating the average of the pain scores marked in the diary during the total surveillance period of one year; 2. '52 Average pain score' (VAS) is determined by calculating the average of the pain scores of calendar weeks during the total surveillance period of one year; 3. 'Positive 52 Average pain score' (VAS) is determined by including the '52 Average pain scores' of those calendar weeks, which have VAS average over 2.

Secondary outcomes

• aMMP-8 [12 Months]: Reduction in inflammation marker aMMP-8 measured by Periosafe®
• Visible plaque index (VPI) [12 Months]: Improvement in visible plaque index (VPI)
• Bleeding on probing index (BOP) [12 Months]: Improvement in the bleeding on probing index (BOP)
• Escudier Index (EI) [12 Months]: Improvement in OLP measured by the Escudier Index (EI)
• Visual Analogue Scale - VAS [12 Months]: Improvement in pain score (Visual Analogue Scale - VAS). Subjects will be asked to rate their pain using a visual analog scale (VAS) from 0-10: 0 = 'no symptoms'; 10 = 'very severe pain'. The amount of improvement in experienced pain is calculated by the following formula: N = \[100% × (pre-treatment VAS score-post treatment VAS score)\]/pre-treatment VAS score. This result is classified as follows: score 5 = lack of pain or discomfort N=100%; score 4 = marked improvement 75%≤N<100%; scores 3 and 2 = moderate improvement 25%≤N<75%; score 1 = mild improvement 0%<N<25%; score 0 = no improvement N=0. The VAS will be monitored both as a daily home-use diary and as a single question at the clinic during the follow-up visits.
• Visual Analogue Scale - VAS [6 Months]: Improvement in pain score (Visual Analogue Scale - VAS). Subjects will be asked to rate their pain using a visual analog scale (VAS) from 0-10: 0 = 'no symptoms'; 10 = 'very severe pain'. The amount of improvement in experienced pain is calculated by the following formula: N = \[100% × (pre-treatment VAS score-post treatment VAS score)\]/pre-treatment VAS score. This result is classified as follows: score 5 = lack of pain or discomfort N=100%; score 4 = marked improvement 75%≤N<100%; scores 3 and 2 = moderate improvement 25%≤N<75%; score 1 = mild improvement 0%<N<25%; score 0 = no improvement N=0. The VAS will be monitored both as a daily home-use diary and as a single question at the clinic during the follow-up visits.
• Visual Analogue Scale - VAS [3 Months]: Improvement in pain score (Visual Analogue Scale - VAS). Subjects will be asked to rate their pain using a visual analog scale (VAS) from 0-10: 0 = 'no symptoms'; 10 = 'very severe pain'. The amount of improvement in experienced pain is calculated by the following formula: N = \[100% × (pre-treatment VAS score-post treatment VAS score)\]/pre-treatment VAS score. This result is classified as follows: score 5 = lack of pain or discomfort N=100%; score 4 = marked improvement 75%≤N<100%; scores 3 and 2 = moderate improvement 25%≤N<75%; score 1 = mild improvement 0%<N<25%; score 0 = no improvement N=0. The VAS will be monitored both as a daily home-use diary and as a single question at the clinic during the follow-up visits.
• Oral Lichen Planus (OLP) relapse [12 Months]: Improvement in OLP relapse rate measured by a decreased need for additional/ repeated treatment with corticosteroid treatment, tacrolimus, or other anti-inflammatory treatment
• Use of corticosteroid treatment [6 Months]: Reduction in the use of corticosteroid treatment according to the anti-inflammatory potency
• Graded chronic pain scale (GCPS) questionnaire (authors: Von Korff M et al. 1992) [12 Months]: Improvement in psychosocial factors assessed by the graded chronic pain scale (GCPS) questionnaire. Grading is based on answering a ten-scale questionnaire from 0, 'no pain' to 10, 'worst possible pain'.
• Oral Health Impact Profile (OHIP-14) questionnaire (author: Slade 1997) [12 Months]: Improvement in psychosocial factors assessed by the oral health impact profile-14 (OHIP-14) questionnaire. The OHIP-14 is a questionnaire that measures people's perception of the social impact of oral disorders on their well-being. Fourteen items of OHIP are divided into seven dimensions: functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability, and handicaps. Grading is based on answering a five-scale questionnaire from 'Never' to 'Very often'.
• Generalized anxiety disorder (GAD-7) questionnaire (authors: Spitzer RL et al. 2006) [12 Months]: Improvement in psychosocial factors assessed by the generalized anxiety disorder (GAD-7) questionnaires. Grading is based on answering a four-scale questionnaire from 0, 'never' to 3, 'almost daily'.
• Oral candidosis [12 Months]: Reduction in number of subjects with oral candidosis during the treatment
• Desquamative gingivitis clinical score (DGCS) [12 Months]: Improvement in OLP measured by the Desquamative Gingivitis Clinical Score (DGCS) by 20 %. The DGCS is a scoring system specifically designed to score the gingival lesions of oral lichen planus. Scoring: 0 = no detectable lesions present; 1 = white lesion; 2 = mild erythema (< 3 mm from gingival margins); 3 = bulla or marked erythema (> 3 mm from gingival margins); 4 = erosion or ulcer

Sex: All, ages: 18 Years to 85 Years

Inclusion Criteria:

* Histologically confirmed diagnosis of OLP with bilateral symmetrical lesions and gingival involvement
* Able to provide a written consent
* Willing and able to complete questionnaires
* Able to co-operate with the treatment protocol and avoid any other oral hygiene measures outside of the study protocol

Exclusion Criteria:

* Lichenoid lesions suspected to be induced by contact allergy or drugs
* Any treatment for OLP in two weeks prior to the study/ a history of topical therapy for OLP in the past 2 weeks or systemic therapy in the past 4 weeks;
* Pregnant or lactating
* Photosensitivity
* Use of antibiotics within 2 weeks prior the study

• Tommi Pätilä, Docent, Study director, Chief Medical Officer