Oral Lichen PlanusRELIEF-OLPNCT05401201

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

A study testing Lumoral treatment and Standard oral hygiene self care in people with Oral Lichen Planus and Dental Plaque, run by Koite Health Oy at 2 sites in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Oral Lichen Planus, Dental Plaque, Oral Bacterial Infection
What is being tested?: Lumoral treatment and Standard oral hygiene self care
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 2 sitesFinland
Study dates: 24 Feb 2023to 13 Apr 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Finland2 sites

Tampere University Hospital, Oral and maxillofacial diseases
Tampere, Pirkanmaa, 33520
Wellbeing services County Pirkanmaa, Health Services, Orthodontics and specialized dental care
Tampere, Pirkanmaa, 33520

Other trials in Finland

About this study

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

Read the 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.

Conditions: Oral Lichen Planus, Dental Plaque, Oral Bacterial Infection
Being tested: Lumoral treatment, Standard oral hygiene self care
Keywords: Lumoral, Lumorinse, Plaque, Oral Lichen Planus, aMMP-8, aPDT, Pain score (VAS)
Medical subject headings: Lichen Planus, Oral, Dental Plaque, Plaque, Amyloid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lumoral treatmentDevice
Also called Lumorinse mouth rinse
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
Also called Sonic toothbrush provided
Both groups shall be given oral and written instructions for twice-daily standard oral hygiene self care.

Study groups in NCT05401201
Study group	Role	What they receive
Study group	Experimental	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. Receives: Device: Lumoral treatment; Other: Standard oral hygiene self care
Control group	Active comparator	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. Receives: Other: Standard oral hygiene self care

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 months

Secondary outcomes (14)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Feb 202313 Apr 2026

First posted2 Jun 2022
Study start24 Feb 2023
Primary completion1 Apr 2026
Study completion13 Apr 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05401201
Sponsor's protocol ID: OLP-01TRE
Acronym: RELIEF-OLP
Status last verified: Apr 2026
First submitted: 27 May 2022
Last updated: 17 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The IPD will only be administered by the researchers that are listed in the CIP.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
Not yet recruiting
Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus
Oral Lichen Planus
Not yet recruiting
Adherence to Topical and Systemic Medications Among Symptomatic Oral Lichen Planus Patients: A Pilot Randomized Clinical Trial
Degree of Adherence of Symptomatic OLP Patients to Their Medications
Active, not recruitingPhase 4
Low Level Laser Therapy With Injectable Platelet Rich Fibrin in Management of Oral Lichen Planus
Oral Lichen Planus
Active, not recruiting
Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
Erythroplakia, Fanconi Anemia

All Oral Lichen Planus trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05401201
Acronym / sponsor ID: RELIEF-OLP / OLP-01TRE
Conditions: Oral Lichen Planus, Dental Plaque, Oral Bacterial Infection
Keywords: Lumoral, Lumorinse, Plaque, Oral Lichen Planus, aMMP-8, aPDT, Pain score (VAS)
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: Koite Health OyIndustry (pharma, biotech, devices)
Collaborators: Wellbeing Services County of Pirkanmaa, Tampere University, University of Helsinki, Tampere University Hospital
Study start: 24 Feb 2023 (actual)
Primary completion: 1 Apr 2026 (actual)
Study completion: 13 Apr 2026 (actual)
First posted: 2 Jun 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Primary outcome is improvement in average Pain score (VAS) symptom diary during the 12 month study period.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Study group	Experimental	Device: Lumoral treatment, Other: Standard oral hygiene self careSubjects 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	Active comparator	Other: Standard oral hygiene self careSubjects 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.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lumoral treatmentAlso: Lumorinse mouth rinseThe 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.	Device	Study group
Standard oral hygiene self careAlso: Sonic toothbrush providedBoth groups shall be given oral and written instructions for twice-daily standard oral hygiene self care.	Other	Control group, Study group

Primary outcome

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: 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.

14 secondary outcomes

aMMP-8
Time frame: 12 Months
Visible plaque index (VPI)
Time frame: 12 Months
Bleeding on probing index (BOP)
Time frame: 12 Months
Escudier Index (EI)
Time frame: 12 Months
Visual Analogue Scale - VAS
Time frame: 12 Months
Visual Analogue Scale - VAS
Time frame: 6 Months
Visual Analogue Scale - VAS
Time frame: 3 Months
Oral Lichen Planus (OLP) relapse
Time frame: 12 Months
Use of corticosteroid treatment
Time frame: 6 Months
Graded chronic pain scale (GCPS) questionnaire (authors: Von Korff M et al. 1992)
Time frame: 12 Months
Oral Health Impact Profile (OHIP-14) questionnaire (author: Slade 1997)
Time frame: 12 Months
Generalized anxiety disorder (GAD-7) questionnaire (authors: Spitzer RL et al. 2006)
Time frame: 12 Months
Oral candidosis
Time frame: 12 Months
Desquamative gingivitis clinical score (DGCS)
Time frame: 12 Months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
Alaijah, F., Morsi, A., Nasher, R. et al. Photobiomodulation therapy in the treatment of periodontal disease: a literature reviewLink provided by the sponsor.
Al-Hashimi I, Schifter M, Lockhart PB, et al., (2007) Oral lichen planus and oral lichenoid lesions: diagnostic and therapeutic considerationsLink provided by the sponsor.
Akram Z, Javed F, Hosein M, et al., (2018) Photodynamic therapy in the treatment of symptomatic oral lichen planus: A systematic review.Link provided by the sponsor.
Arduino PG, Broccoletti R, Sciannameo V, Scully C. (2017) A practical clinical recording system for cases of desquamative gingivitisLink provided by the sponsor.
Cheng YS, Gould A, Kurago Z, Fantasia J, Muller S. (2016) Diagnosis of oral lichen planus: a position paper of the American Academy of Oral and Maxillofacial PathologyLink provided by the sponsor.
Escudier M, Ahmed N, Shirlaw P, et al., (2007) A scoring system for mucosal disease severity with special reference to oral lichen planus.Link provided by the sponsor.
Individual participant dataSharing planned: No. The IPD will only be administered by the researchers that are listed in the CIP.

Related trials for Oral Lichen Planus

RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
Not yet recruiting
Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus
Oral Lichen Planus
Not yet recruiting
Adherence to Topical and Systemic Medications Among Symptomatic Oral Lichen Planus Patients: A Pilot Randomized Clinical Trial
Degree of Adherence of Symptomatic OLP Patients to Their Medications
Active, not recruitingPhase 4
Low Level Laser Therapy With Injectable Platelet Rich Fibrin in Management of Oral Lichen Planus
Oral Lichen Planus
Active, not recruiting
Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
Erythroplakia, Fanconi Anemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tommi Pätilä, Docent study director

Chief Medical Officer

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Lumoral treatment and Standard oral hygiene self care in people with Oral Lichen Planus and Dental Plaque, run by Koite Health Oy at 2 sites in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain score symptom diary (based on Visual Analogue Scale - VAS) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05401201.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.