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

Dental Plaque Clinical Trial

— RELIEF-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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05401201
• Other study ID #: OLP-01TRE
• Status: Recruiting
• Phase: N/A
• Start date: February 24, 2023
• Est. completion date: July 31, 2027

Study information

• Verified date: April 2024
• Source: Koite Health Oy
• Contact: Mikko Kylmänen
• Phone: +358407245934
• Email: mikko.kylmanen[@]koitehealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 31, 2027
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Dental Plaque
• Lichen Planus
• Lichen Planus, Oral
• Oral Bacterial Infection
• Oral Lichen Planus

Intervention

Device:
• Lumoral treatment
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.

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

Locations

Country	Name	City	State
Finland	Tampere University Hospital, Oral and maxillofacial diseases	Tampere	Pirkanmaa
Finland	Wellbeing services County Pirkanmaa, Health Services, Orthodontics and specialized dental care	Tampere	Pirkanmaa

Sponsors (5)

Lead Sponsor	Collaborator
Koite Health Oy	Tampere University, Tampere University Hospital, University of Helsinki, Wellbeing Services County of Pirkanmaa

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: '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; '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; '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.	12 months
Secondary	aMMP-8	Reduction in inflammation marker aMMP-8 measured by Periosafe®	12 Months
Secondary	Visible plaque index (VPI)	Improvement in visible plaque index (VPI)	12 Months
Secondary	Bleeding on probing index (BOP)	Improvement in the bleeding on probing index (BOP)	12 Months
Secondary	Escudier Index (EI)	Improvement in OLP measured by the Escudier Index (EI)	12 Months
Secondary	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%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.	12 Months
Secondary	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%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.	6 Months
Secondary	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%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.	3 Months
Secondary	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
Secondary	Use of corticosteroid treatment	Reduction in the use of corticosteroid treatment according to the anti-inflammatory potency	6 Months
Secondary	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
Secondary	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
Secondary	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
Secondary	Oral candidosis	Reduction in number of subjects with oral candidosis during the treatment	12 Months
Secondary	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

External Links

•   Akram Z, Javed F, Hosein M, et al., (2018) Photodynamic therapy in the treatment of symptomatic oral lichen planus: A systematic review.
•   Al-Hashimi I, Schifter M, Lockhart PB, et al., (2007) Oral lichen planus and oral lichenoid lesions: diagnostic and therapeutic considerations
•   Alaijah, F., Morsi, A., Nasher, R. et al. Photobiomodulation therapy in the treatment of periodontal disease: a literature review
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•   Gorouhi F, Davari P, Fazel N (2014) Cutaneous and mucosal lichen planus: a comprehensive review of clinical subtypes, risk factors, diagnosis, and prognosis
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•   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.
•   Nikinmaa S, Moilanen N, Sorsa T, et al. (2021a). Indocyanine Green-Assisted and LED-Light-Activated Antibacterial Photodynamic Therapy Reduces Dental Plaque.
•   Nikinmaa S, Podonyi A, Raivio P, et al. (2021b). Daily Administered Dual-Light Photodynamic Therapy Provides a Sustained Antibacterial Effect on Staphylococcus aureus
•   Piboonniyom SO, Treister N, Pitiphat W, Woo SB. (2005) Scoring system for monitoring oral lichenoid lesions: a preliminary study.
•   Slade GD (1997) Derivation and validation of a short-form oral health impact profile
•   Spitzer RL, Kroenke K, Williams JBW, Löwe B (2006) A brief measure for assessing generalized anxiety disorder: the GAD-7
•   Von Korff M, Ormel J, Keefe FJ, Dworkin SF (1992) Grading the severity of chronic pain