Dual-light Antibacterial Photodynamic Therapy as an Adjunctive Treatment to Corticosteroid Treatment in OLP
- Conditions
- Dental PlaqueOral Bacterial InfectionOral Lichen Planus
- Interventions
- Device: Lumoral treatmentOther: Standard oral hygiene self care
- Registration Number
- NCT05401201
- Lead Sponsor
- Koite Health Oy
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study group Lumoral treatment 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. Study group Standard oral hygiene self care 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 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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'.
aMMP-8 12 Months Reduction in inflammation marker aMMP-8 measured by Periosafe®
Bleeding on probing index (BOP) 12 Months Improvement in the bleeding on probing index (BOP)
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
Escudier Index (EI) 12 Months Improvement in OLP measured by the Escudier Index (EI)
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.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'.
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
Visible plaque index (VPI) 12 Months Improvement in visible plaque index (VPI)
Use of corticosteroid treatment 6 Months Reduction in the use of corticosteroid treatment according to the anti-inflammatory potency
Oral candidosis 12 Months Reduction in number of subjects with oral candidosis during the treatment
Trial Locations
- Locations (2)
Tampere University Hospital, Oral and maxillofacial diseases
🇫🇮Tampere, Pirkanmaa, Finland
Wellbeing services County Pirkanmaa, Health Services, Orthodontics and specialized dental care
🇫🇮Tampere, Pirkanmaa, Finland