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| Name | Class |
|---|---|
| Wellbeing Services County of Pirkanmaa | OTHER |
| Tampere University | OTHER |
| University of Helsinki | OTHER |
| Tampere University Hospital |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | 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. |
|
| Control group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumoral treatment | Device | 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. |
| 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:
| 12 months |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tommi Pätilä, Docent | Chief Medical Officer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampere University Hospital, Oral and maxillofacial diseases | Tampere | Pirkanmaa | 33520 | Finland | ||
| Wellbeing services County Pirkanmaa, Health Services, Orthodontics and specialized dental care |
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| Label | URL |
|---|---|
| Alaijah, F., Morsi, A., Nasher, R. et al. Photobiomodulation therapy in the treatment of periodontal disease: a literature review | View source |
| Al-Hashimi I, Schifter M, Lockhart PB, et al., (2007) Oral lichen planus and oral lichenoid lesions: diagnostic and therapeutic considerations | View source |
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The IPD will only be administered by the researchers that are listed in the CIP.
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| ID | Term |
|---|---|
| D017676 | Lichen Planus, Oral |
| D003773 | Dental Plaque |
| D058225 | Plaque, Amyloid |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D008010 | Lichen Planus |
| D017512 | Lichenoid Eruptions |
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| OTHER |
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.
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A sealed envelope system shall be used for randomization.
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|
|
| Standard oral hygiene self care | Other | Both groups shall be given oral and written instructions for twice-daily standard oral hygiene self care. |
|
|
| 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%\ | 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%\ | 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%\ | 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 |
| Tampere |
| Pirkanmaa |
| 33520 |
| Finland |
| Akram Z, Javed F, Hosein M, et al., (2018) Photodynamic therapy in the treatment of symptomatic oral lichen planus: A systematic review. | View source |
| Arduino PG, Broccoletti R, Sciannameo V, Scully C. (2017) A practical clinical recording system for cases of desquamative gingivitis | View source |
| Cheng YS, Gould A, Kurago Z, Fantasia J, Muller S. (2016) Diagnosis of oral lichen planus: a position paper of the American Academy of Oral and Maxillofacial Pathology | View source |
| Escudier M, Ahmed N, Shirlaw P, et al., (2007) A scoring system for mucosal disease severity with special reference to oral lichen planus. | View source |
| He Y, Deng J, Zhao Y, Tao H et al., (2020) Efficacy evaluation of photodynamic therapy for oral lichen planus: a systematic review and meta-analysis. | View source |
| Levine JI. Medications that increase photosensititivity. | View source |
| Nikinmaa S, Alapulli H, Auvinen P, et al. (2020) Dual-light photodynamic therapy administered daily provides a sustained antibacterial effect on biofilm and prevents Streptococcus mutans adaptation. | View source |
| Nikinmaa S, Moilanen N, Sorsa T, et al. (2021a). Indocyanine Green-Assisted and LED-Light-Activated Antibacterial Photodynamic Therapy Reduces Dental Plaque. | View source |
| Nikinmaa S, Podonyi A, Raivio P, et al. (2021b). Daily Administered Dual-Light Photodynamic Therapy Provides a Sustained Antibacterial Effect on Staphylococcus aureus | View source |
| Piboonniyom SO, Treister N, Pitiphat W, Woo SB. (2005) Scoring system for monitoring oral lichenoid lesions: a preliminary study. | View source |
| Slade GD (1997) Derivation and validation of a short-form oral health impact profile | View source |
| Spitzer RL, Kroenke K, Williams JBW, Löwe B (2006) A brief measure for assessing generalized anxiety disorder: the GAD-7 | View source |
| Von Korff M, Ormel J, Keefe FJ, Dworkin SF (1992) Grading the severity of chronic pain | View source |
| NICE Guidance IPG615. Low-level laser therapy for preventing or treating oral mucositis caused by radiotherapy or chemotherapy. Interventional procedures guidance \[IPG615\]. Published: 23 May 2018. | View source |
| D017444 |
| Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |