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

N/AActive Not RecruitingNCT05401201

Koite Health Oy60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Conditions

Oral Lichen Planus Dental Plaque Oral Bacterial Infection

Interventions

Lumoral treatmentDEVICE

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 careOTHER

Both groups shall be given oral and written instructions for twice-daily standard oral hygiene self care.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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