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Completed

NCT Number: NCT05401201

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

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).

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Key information

Conditions

Oral Lichen Planus Dental Deposits Dental Plaque Lichen Planus Lichen Planus, Oral Lichenoid Eruptions Mouth Diseases Oral Bacterial Infection Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Plaque, Amyloid Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tampere University Hospital, Oral and maxillofacial diseases, Tampere, Pirkanmaa, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Lumorinse mouth rinse

Standard oral hygiene self care

Other

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

Other names: Sonic toothbrush provided

Primary outcomes

  1. Pain score symptom diary (based on Visual Analogue Scale - VAS)

    Time frame: 12 months

    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.

Secondary outcomes

  1. aMMP-8

    Time frame: 12 Months

    Reduction in inflammation marker aMMP-8 measured by Periosafe®

  2. Visible plaque index (VPI)

    Time frame: 12 Months

    Improvement in visible plaque index (VPI)

  3. Bleeding on probing index (BOP)

    Time frame: 12 Months

    Improvement in the bleeding on probing index (BOP)

  4. Escudier Index (EI)

    Time frame: 12 Months

    Improvement in OLP measured by the Escudier Index (EI)

  5. Visual Analogue Scale - VAS

    Time frame: 12 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.

  6. Visual Analogue Scale - VAS

    Time frame: 6 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.

  7. Visual Analogue Scale - VAS

    Time frame: 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.

  8. Oral Lichen Planus (OLP) relapse

    Time frame: 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

  9. Use of corticosteroid treatment

    Time frame: 6 Months

    Reduction in the use of corticosteroid treatment according to the anti-inflammatory potency

  10. Graded chronic pain scale (GCPS) questionnaire (authors: Von Korff M et al. 1992)

    Time frame: 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'.

  11. Oral Health Impact Profile (OHIP-14) questionnaire (author: Slade 1997)

    Time frame: 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'.

  12. Generalized anxiety disorder (GAD-7) questionnaire (authors: Spitzer RL et al. 2006)

    Time frame: 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'.

  13. Oral candidosis

    Time frame: 12 Months

    Reduction in number of subjects with oral candidosis during the treatment

  14. Desquamative gingivitis clinical score (DGCS)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Koite Health Oy

Industry

Collaborators

  • Tampere University
  • Tampere University Hospital
  • University of Helsinki
  • Wellbeing Services County of Pirkanmaa

Registry information

Official study 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

Acronym: RELIEF-OLP

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 2, 2022
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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