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

Study Overview
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Brief Summary
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This study is designed to investigate the effectiveness of plaque control intervention by home-use dual-light aPDT Lumoral -device as an adjunctive or alternative treatment to triamcinolone acetonide (TCA) mouth rinse or other topical corticosteroid treatment on the symptoms and clinical appearance of symptomatic gingival involvement of oral lichen planus (OLP).

Detailed Description
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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.

Official Title
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Dual-light Antibacterial Photodynamic Therapy as an Adjunctive Treatment to Topical Corticosteroid Treatment in Patients With Gingival Involvement of Oral Lichen Planus - a Randomized Study

Conditions
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Oral Lichen Planus, Dental Plaque, Oral Bacterial Infection

Intervention / Treatment
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* Device: Lumoral treatment
* Other: Standard oral hygiene self care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Subjects in the study group will use the Lumoral device five to seven times a week according to the verbal and written instructions provided to them. In addition, they will brush their teeth twice daily in their customary manner while using the provided sonic toothbrush and regular toothpaste. | Device: Lumoral treatment<br>* 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.<br>* Other names: Lumorinse mouth rinse;Other: Standard oral hygiene self care<br>* Both groups shall be given oral and written instructions for twice-daily standard oral hygiene self care.<br>* Other names: Sonic toothbrush provided;|
| Active Comparator: Control group<br>Subjects in the control group will brush their teeth in their customary manner twice daily while using the provided sonic toothbrush and regular toothpaste. They will not receive any additional intervention. | Other: Standard oral hygiene self care<br>* Both groups shall be given oral and written instructions for twice-daily standard oral hygiene self care.<br>* Other names: Sonic toothbrush provided;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score symptom diary (based on Visual Analogue Scale - VAS) | Improvement in average Pain score (VAS) symptom diary during the 12 month study period. Assessments: '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; '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; '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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| aMMP-8 | Reduction in inflammation marker aMMP-8 measured by Periosafe® | 12 Months | 
| Visible plaque index (VPI) | Improvement in visible plaque index (VPI) | 12 Months | 
| Bleeding on probing index (BOP) | Improvement in the bleeding on probing index (BOP) | 12 Months | 
| Escudier Index (EI) | Improvement in OLP measured by the Escudier Index (EI) | 12 Months | 
| Visual Analogue Scale - VAS | 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. | 12 Months | 
| Visual Analogue Scale - VAS | 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. | 6 Months | 
| Visual Analogue Scale - VAS | 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. | 3 Months | 
| Oral Lichen Planus (OLP) relapse | Improvement in OLP relapse rate measured by a decreased need for additional/ repeated treatment with corticosteroid treatment, tacrolimus, or other anti-inflammatory treatment | 12 Months | 
| Use of corticosteroid treatment | Reduction in the use of corticosteroid treatment according to the anti-inflammatory potency | 6 Months | 
| Graded chronic pain scale (GCPS) questionnaire (authors: Von Korff M et al. 1992) | 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'. | 12 Months | 
| Oral Health Impact Profile (OHIP-14) questionnaire (author: Slade 1997) | 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'. | 12 Months | 
| Generalized anxiety disorder (GAD-7) questionnaire (authors: Spitzer RL et al. 2006) | 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'. | 12 Months | 
| Oral candidosis | Reduction in number of subjects with oral candidosis during the treatment | 12 Months | 
| Desquamative gingivitis clinical score (DGCS) | 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 | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumoral, Lumorinse, Plaque, Oral Lichen Planus, aMMP-8, aPDT, Pain score (VAS)