Clinical trial NCT05401201: Dual-light Antibacterial Photodynamic Therapy as an Adjunctive Treatment to Corticosteroid Treatment in OLP
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oral Lichen Planus
Dental Plaque
Oral Bacterial Infection
Keywords: Lumoral
Lumorinse
Plaque
Oral Lichen Planus
aMMP-8
aPDT
Pain score (VAS)
Lead sponsor: Koite Health Oy
Sponsor class: INDUSTRY
Collaborators: name: Wellbeing Services County of Pirkanmaa
name: Tampere University
name: University of Helsinki
name: Tampere University Hospital
First posted: 2022-06-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain score symptom diary (based on Visual Analogue Scale - VAS)
timeFrame: 12 months
Secondary outcomes:
measure: aMMP-8
timeFrame: 12 Months
measure: Visible plaque index (VPI)
timeFrame: 12 Months
measure: Bleeding on probing index (BOP)
timeFrame: 12 Months
measure: Escudier Index (EI)
timeFrame: 12 Months
measure: Visual Analogue Scale - VAS
timeFrame: 12 Months
measure: Visual Analogue Scale - VAS
timeFrame: 6 Months
measure: Visual Analogue Scale - VAS
timeFrame: 3 Months
measure: Oral Lichen Planus (OLP) relapse
timeFrame: 12 Months
measure: Use of corticosteroid treatment
timeFrame: 6 Months
measure: Graded chronic pain scale (GCPS) questionnaire (authors: Von Korff M et al. 1992)
timeFrame: 12 Months
measure: Oral Health Impact Profile (OHIP-14) questionnaire (author: Slade 1997)
timeFrame: 12 Months
measure: Generalized anxiety disorder (GAD-7) questionnaire (authors: Spitzer RL et al. 2006)
timeFrame: 12 Months
measure: Oral candidosis
timeFrame: 12 Months
measure: Desquamative gingivitis clinical score (DGCS)
timeFrame: 12 Months
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital, Oral and maxillofacial diseases
state: Pirkanmaa
city: Tampere
country: Finland
facility: Wellbeing services County Pirkanmaa, Health Services, Orthodontics and specialized dental care
state: Pirkanmaa
Study officials:
affiliation: Chief Medical Officer
name: Tommi Pätilä, Docent
role: STUDY_DIRECTOR
References: