An interventional study of Lumoral treatment and Standard oral hygiene self care in Oral Lichen Planus, Dental Plaque and Oral Bacterial Infection, sponsored by Koite Health Oy. Completed at 2 sites in Finland. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-04-17.
Sponsored by Koite Health Oy · Not applicable, Interventional, and Supportive care
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).
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.
139 studies on the registry are indexed under Lichen Planus, Oral; 24 are open to participants now.
This study's enrollment of 13 is below the median of 36 across 101 interventional studies indexed under Lichen Planus, Oral.
Browse Lichen Planus, Oral studies →Koite Health Oy is the lead sponsor of 14 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Other: Standard oral hygiene self care
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
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.
Also known as: Lumorinse mouth rinse
Both groups shall be given oral and written instructions for twice-daily standard oral hygiene self care.
Also known as: Sonic toothbrush provided
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: 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.
Time frame: 12 months
aMMP-8
Reduction in inflammation marker aMMP-8 measured by Periosafe®
Time frame: 12 Months
Visible plaque index (VPI)
Improvement in visible plaque index (VPI)
Time frame: 12 Months
Bleeding on probing index (BOP)
Improvement in the bleeding on probing index (BOP)
Time frame: 12 Months
Escudier Index (EI)
Improvement in OLP measured by the Escudier Index (EI)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 12 Months
Use of corticosteroid treatment
Reduction in the use of corticosteroid treatment according to the anti-inflammatory potency
Time frame: 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'.
Time frame: 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'.
Time frame: 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'.
Time frame: 12 Months
Oral candidosis
Reduction in number of subjects with oral candidosis during the treatment
Time frame: 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
Time frame: 12 Months
Plan to share: No — The IPD will only be administered by the researchers that are listed in the CIP.
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